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- Recall Enforcement Event ID: 87907
Recall Enforment Report D-0604-2021
Recall Details
Multi event Drug Recall Enforcement Report Class III voluntary initiated by Fresenius Medical Care Holdings, Inc., originally initiated on 04-28-2021 for the product DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, 5000 mL bags, 2-pack, Rx Only, Fresenius Medical Care NA, Waltham, MA 02451, NDC 49230-0188-50 The product was recalled due to temperature abuse: product exposed to temperature outside specified limits.. The product was distributed nationwide and the recall is currently terminated.
Recall Enforcement Reports
| Recall Number | Recall Initiation Date | Report Date | Recall Classification | Quantity | Product Description | Recall Reason | Status |
|---|---|---|---|---|---|---|---|
| D-0604-2021 | 04-28-2021 | 06-16-2021 | Class III | 25 cases | DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, 5000 mL bags, 2-pack, Rx Only, Fresenius Medical Care NA, Waltham, MA 02451, NDC 49230-0188-50 | Temperature Abuse: Product exposed to temperature outside specified limits. | Terminated |
| D-0606-2021 | 04-28-2021 | 06-16-2021 | Class III | 49 cases | DELFELX Peritoneal Dialysis Solution with 4.25% Dextrose, Low Magnesium, Low Calcium, 5000 mL, Fresenius Medical Care, Waltham, MA 02451, NDC 49230-0212-50 | Temperature Abuse: Product exposed to temperature outside specified limits. | Terminated |
| D-0603-2021 | 04-28-2021 | 06-16-2021 | Class II | 48 cases | Sodium Chloride 0.9%, USP, 1000 mL, Mfg by: Fresenius Medical Care North America, Waltham, MA 02451, NDC 46163-0300-10 | Temperature Abuse: Product exposed to temperature outside specified limits. | Terminated |
| D-0609-2021 | 04-28-2021 | 06-16-2021 | Class III | 4 cases | DELFLEX Peritoneal Dialysis Solution with 4.25% Dextrose, Low magnesium, Low Calcium and attached stay safe Exchange set, 2000 mL, packs of 5, Rx only, Fresenius Medical Care NA, Waltham, MA 02451, NDC 49230-212-92 | Temperature Abuse: Product exposed to temperature outside specified limits. | Terminated |
| D-0607-2021 | 04-28-2021 | 06-16-2021 | Class III | 5 cases | DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, Low magnesium, Low Calcium and attached stay safe Exchange set, 2000 mL Fresenius Medical Care NA, Waltham, MA 02451, NDC 49230-206-92 | Temperature Abuse: Product exposed to temperature outside specified limits. | Terminated |
| D-0605-2021 | 04-28-2021 | 06-16-2021 | Class III | 672 cases | DELFLEX Peritoneal Dialysis Solution with 2.5 % Dextrose, Low Magnesium, Low Calcium, packaged in a) 3000 mL 2 packs (NDC 49230-0209-23), b) 3000 mL (NDC 49230-209-30) and c) 5000 mL (NDC 49230-209-50) Rx only, Fresenius Medical Care NA Waltham, MA 02451 | Temperature Abuse: Product exposed to temperature outside specified limits. | Terminated |
| D-0610-2021 | 04-28-2021 | 06-16-2021 | Class III | 285 cases | DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, Low magnesium, Low Calcium, packaged in a) 3000 mL bags (NDC 49230-206-30) and b) 5000mL bags, 2 packs (NDC 49230-206-50), Rx only, Fresenius Medical Care NA, Waltham, MA 02451 | Temperature Abuse: Product exposed to temperature outside specified limits. | Terminated |
| D-0608-2021 | 04-28-2021 | 06-16-2021 | Class III | 39 cases | DELFLEX Peritoneal Dialysis Solution with 2.5% Dextrose, Low magnesium, Low Calcium and attached stay safe Exchange set, packaged in a) 2500 mL (NDC 49230-209-94) and b) 2000mL, packs of 5 (NDC 49230-209-92) Fresenius Medical Care NA, Waltham, MA 02451, | Temperature Abuse: Product exposed to temperature outside specified limits. | Terminated |
Recalled Products
| NDC | Proprietary Name | Non-Proprietary Name | Dosage Form | Route Name | Company Name | Product Type |
|---|---|---|---|---|---|---|
| 49230-206 | Delflex | Fresenius Medical Care North America | ||||
| 49230-206 | Delflex Neutral Ph | Fresenius Medical Care North America | ||||
| 49230-206 | Delflex Neutral Ph | Fresenius Medical Care North America | ||||
| 49230-206 | Delflex Neutral Ph with attached stay-safe Exchange Set | Fresenius Medical Care North America | ||||
| 49230-206 | Delflex Neutral Ph with attached stay-safe Exchange Set | Fresenius Medical Care North America | ||||
| 49230-206 | Delflex | Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride | Solution | Intraperitoneal | Fresenius Medical Care North America | Human Prescription Drug |
| 49230-209 | Delflex | Fresenius Medical Care North America | ||||
| 49230-209 | Delflex Neutral Ph | Fresenius Medical Care North America | ||||
| 49230-209 | Delflex Neutral Ph | Fresenius Medical Care North America | ||||
| 49230-209 | Delflex Neutral Ph with attached stay-safe Exchange Set | Fresenius Medical Care North America | ||||
| 49230-209 | Delflex Neutral Ph with attached stay-safe Exchange Set | Fresenius Medical Care North America | ||||
| 49230-209 | Delflex | Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride | Solution | Intraperitoneal | Fresenius Medical Care North America | Human Prescription Drug |
| 49230-212 | Delflex | Fresenius Medical Care North America | ||||
| 49230-212 | Delflex Neutral Ph | Fresenius Medical Care North America | ||||
| 49230-212 | Delflex Neutral Ph | Fresenius Medical Care North America | ||||
| 49230-212 | Delflex Neutral Ph with attached stay-safe Exchange Set | Fresenius Medical Care North America | ||||
| 49230-212 | Delflex Neutral Ph with attached stay-safe Exchange Set | Fresenius Medical Care North America | ||||
| 49230-212 | Delflex | Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride | Solution | Intraperitoneal | Fresenius Medical Care North America | Human Prescription Drug |
Recall Enforcement Report D-0604-2021
- Event ID
- 87907 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0604-2021 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences. What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, 5000 mL bags, 2-pack, Rx Only, Fresenius Medical Care NA, Waltham, MA 02451, NDC 49230-0188-50
- Reason For Recall
- Temperature Abuse: Product exposed to temperature outside specified limits. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 25 cases Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 06-16-2021
- Recall Initiation Date
- 04-28-2021 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 09-17-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Fresenius Medical Care Holdings, Inc.
- Code Info
- Lot #: 20JU01001, Exp. Date February 2022 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0606-2021
- Event ID
- 87907 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0606-2021 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences. What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- DELFELX Peritoneal Dialysis Solution with 4.25% Dextrose, Low Magnesium, Low Calcium, 5000 mL, Fresenius Medical Care, Waltham, MA 02451, NDC 49230-0212-50
- Reason For Recall
- Temperature Abuse: Product exposed to temperature outside specified limits. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 49 cases Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 06-16-2021
- Recall Initiation Date
- 04-28-2021 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 09-17-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Fresenius Medical Care Holdings, Inc.
- Code Info
- Lot #: 21AK01022, Exp. date July 2022; 20SK01022, Exp. date June 2022 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0603-2021
- Event ID
- 87907 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0603-2021 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Sodium Chloride 0.9%, USP, 1000 mL, Mfg by: Fresenius Medical Care North America, Waltham, MA 02451, NDC 46163-0300-10
- Reason For Recall
- Temperature Abuse: Product exposed to temperature outside specified limits. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 48 cases Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 06-16-2021
- Recall Initiation Date
- 04-28-2021 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 09-17-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Fresenius Medical Care Holdings, Inc.
- Code Info
- Lot #: 20NG02095, Exp. Date October 2021 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0609-2021
- Event ID
- 87907 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0609-2021 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences. What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- DELFLEX Peritoneal Dialysis Solution with 4.25% Dextrose, Low magnesium, Low Calcium and attached stay safe Exchange set, 2000 mL, packs of 5, Rx only, Fresenius Medical Care NA, Waltham, MA 02451, NDC 49230-212-92
- Reason For Recall
- Temperature Abuse: Product exposed to temperature outside specified limits. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 4 cases Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 06-16-2021
- Recall Initiation Date
- 04-28-2021 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 09-17-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Fresenius Medical Care Holdings, Inc.
- Code Info
- Lot #: 20PU04030, Exp. date June 2022 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 49230-206-92; 49230-206-94; 49230-206-95; 49230-209-92; 49230-209-94; 49230-209-95; 49230-212-92; 49230-212-94; 49230-212-95
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0607-2021
- Event ID
- 87907 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0607-2021 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences. What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, Low magnesium, Low Calcium and attached stay safe Exchange set, 2000 mL Fresenius Medical Care NA, Waltham, MA 02451, NDC 49230-206-92
- Reason For Recall
- Temperature Abuse: Product exposed to temperature outside specified limits. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 5 cases Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 06-16-2021
- Recall Initiation Date
- 04-28-2021 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 09-17-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Fresenius Medical Care Holdings, Inc.
- Code Info
- Lot #: 20SU02032, Exp. date July 2022 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 49230-206-92; 49230-206-94; 49230-206-95; 49230-209-92; 49230-209-94; 49230-209-95; 49230-212-92; 49230-212-94; 49230-212-95
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0605-2021
- Event ID
- 87907 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0605-2021 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences. What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- DELFLEX Peritoneal Dialysis Solution with 2.5 % Dextrose, Low Magnesium, Low Calcium, packaged in a) 3000 mL 2 packs (NDC 49230-0209-23), b) 3000 mL (NDC 49230-209-30) and c) 5000 mL (NDC 49230-209-50) Rx only, Fresenius Medical Care NA Waltham, MA 02451
- Reason For Recall
- Temperature Abuse: Product exposed to temperature outside specified limits. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 672 cases Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 06-16-2021
- Recall Initiation Date
- 04-28-2021 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 09-17-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Fresenius Medical Care Holdings, Inc.
- Code Info
- Lot #: a) 20PU03043, Exp. Date June 2022; b) 20SU03036, Exp. date July 2022; c) 20Su07012, Exp. date July 2022; 21AU07021, 21AU02037, 21AU01007, 21AU01006, 21AU01019, Exp. date August 2022 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 49230-206-20; 49230-206-30; 49230-206-32; 49230-206-50; 49230-206-60; 49230-206-62; 49230-206-52; 49230-209-23; 49230-209-30; 49230-209-32; 49230-209-50; 49230-209-60; 49230-209-62; 49230-209-52; 49230-212-23; 49230-212-30; 49230-212-32; 49230-212-50; 49230-212-60; 49230-212-62; 49230-212-52; 49230-0209-23
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0610-2021
- Event ID
- 87907 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0610-2021 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences. What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, Low magnesium, Low Calcium, packaged in a) 3000 mL bags (NDC 49230-206-30) and b) 5000mL bags, 2 packs (NDC 49230-206-50), Rx only, Fresenius Medical Care NA, Waltham, MA 02451
- Reason For Recall
- Temperature Abuse: Product exposed to temperature outside specified limits. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 285 cases Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 06-16-2021
- Recall Initiation Date
- 04-28-2021 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 09-17-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Fresenius Medical Care Holdings, Inc.
- Code Info
- Lot #: a) 20SU03060, Exp Date. July 2022; b) 21AU02015, 21AU02038, Exp. Date August 2022 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 49230-206-20; 49230-206-30; 49230-206-32; 49230-206-50; 49230-206-60; 49230-206-62; 49230-206-52; 49230-209-23; 49230-209-30; 49230-209-32; 49230-209-50; 49230-209-60; 49230-209-62; 49230-209-52; 49230-212-23; 49230-212-30; 49230-212-32; 49230-212-50; 49230-212-60; 49230-212-62; 49230-212-52
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0608-2021
- Event ID
- 87907 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0608-2021 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences. What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- DELFLEX Peritoneal Dialysis Solution with 2.5% Dextrose, Low magnesium, Low Calcium and attached stay safe Exchange set, packaged in a) 2500 mL (NDC 49230-209-94) and b) 2000mL, packs of 5 (NDC 49230-209-92) Fresenius Medical Care NA, Waltham, MA 02451,
- Reason For Recall
- Temperature Abuse: Product exposed to temperature outside specified limits. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 39 cases Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 06-16-2021
- Recall Initiation Date
- 04-28-2021 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 09-17-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Fresenius Medical Care Holdings, Inc.
- Code Info
- Lot #: a) 20PU02010, Exp. date June 2022 and b) 20SU04033, Exp. date July 2022 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 49230-206-92; 49230-206-94; 49230-206-95; 49230-209-92; 49230-209-94; 49230-209-95; 49230-212-92; 49230-212-94; 49230-212-95
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
