Delflex Solution
FDA Recall NDC 49230-206
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 9 recorded enforcement report(s) associated with Delflex (NDC 49230-206). A significant event, classified as Class II, was initiated on Jun 18, 2024 by Fresenius Medical Care Renal Therapies Group, Llc. The reported reason for this action was: "This product is being recalled due to the tube weld failure presents itself as a slow leak and can be difficult to detect."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
June 2024 Class II Recall: This product is being recalled due to the tube weld failure presents itself as a slow leak and can be difficult to detect.
Recall Number
Class II Ongoing
This product is being recalled due to the tube weld failure presents itself as a slow leak and can be difficult to detect.
Jun 18, 2024
Jul 24, 2024
183 cases
Recall Profile & Regulatory Data
Event ID
94887
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Fresenius Medical Care Holdings, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Product Description
DELFLEX PERITONEAL DIALYSIS SOLUTION With LOW MAGNESIUM / LOW CALCIUM 4.25% DEXTROSE and attached stay "safe Exchange Set, 2500mL (Approx. 50 mL excess), Single Dose Container Sterile and Non-Pyrogenic, For Intraperitoneal Administration Only, Fresenius Medical Care NA Waltham, MA 02451, 1-800-323-5188 NDC 49230-212-94
Batch or Lot Expiration Information
Lot# 24AU03024, exp. date 07/31/2025
Affected Packages Involved in this Recall
49230-206-92Product
49230-206-94Product
49230-206-95Product
49230-209-92Product
49230-209-94Product
49230-209-95Product
49230-212-92Product
49230-212-94Product
49230-212-95Product
Class II Ongoing
Lack of Sterility Assurance
Dec 28, 2023
Jan 10, 2024
69,590 bags
Recall Profile & Regulatory Data
Event ID
93690
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Fresenius Medical Care Holdings, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Product Description
DELFLEX Peritoneal Dialysis Solution in Biofine container 1.5% Dextrose, packaged in 6000mL bags, Rx only, Fresenius Medical Care NA Waltham, MA 02451, NDC 49230-206-62.
Batch or Lot Expiration Information
Lot# Part Number: 077-60621
Lot# : 23JK02010, Exp. Date 1/31/2025
Affected Packages Involved in this Recall
49230-206-20Product
49230-206-30Product
49230-206-32Product
49230-206-50Product
49230-206-60Product
49230-206-62Product
49230-206-52Product
49230-209-23Product
49230-209-30Product
49230-209-32Product
49230-209-50Product
49230-209-60Product
49230-209-62Product
49230-209-52Product
49230-212-23Product
49230-212-30Product
49230-212-32Product
49230-212-50Product
49230-212-60Product
49230-212-62Product
49230-212-52Product
Class III Terminated
Temperature Abuse: Product exposed to temperature outside specified limits.
Apr 28, 2021
Jun 16, 2021
39 cases
Recall Profile & Regulatory Data
Event ID
87907
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Fresenius Medical Care Holdings, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Termination Date
Sep 17, 2021
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,
Batch or Lot Expiration Information
Lot# : a) 20PU02010, Exp. date June 2022 and b) 20SU04033, Exp. date July 2022
Affected Packages Involved in this Recall
49230-206-92Product
49230-206-94Product
49230-206-95Product
49230-209-92Product
49230-209-94Product
49230-209-95Product
49230-212-92Product
49230-212-94Product
49230-212-95Product
Class III Terminated
Temperature Abuse: Product exposed to temperature outside specified limits.
Apr 28, 2021
Jun 16, 2021
285 cases
Recall Profile & Regulatory Data
Event ID
87907
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Fresenius Medical Care Holdings, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Termination Date
Sep 17, 2021
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
Batch or Lot Expiration Information
Lot# : a) 20SU03060, Exp Date. July 2022; b) 21AU02015, 21AU02038, Exp. Date August 2022
Affected Packages Involved in this Recall
49230-206-20Product
49230-206-30Product
49230-206-32Product
49230-206-50Product
49230-206-60Product
49230-206-62Product
49230-206-52Product
49230-209-23Product
49230-209-30Product
49230-209-32Product
49230-209-50Product
49230-209-60Product
49230-209-62Product
49230-209-52Product
49230-212-23Product
49230-212-30Product
49230-212-32Product
49230-212-50Product
49230-212-60Product
49230-212-62Product
49230-212-52Product
Class III Terminated
Temperature Abuse: Product exposed to temperature outside specified limits.
Apr 28, 2021
Jun 16, 2021
4 cases
Recall Profile & Regulatory Data
Event ID
87907
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Fresenius Medical Care Holdings, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Termination Date
Sep 17, 2021
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
Batch or Lot Expiration Information
Lot# : 20PU04030, Exp. date June 2022
Affected Packages Involved in this Recall
49230-206-92Product
49230-206-94Product
49230-206-95Product
49230-209-92Product
49230-209-94Product
49230-209-95Product
49230-212-92Product
49230-212-94Product
49230-212-95Product
Class III Terminated
Temperature Abuse: Product exposed to temperature outside specified limits.
Apr 28, 2021
Jun 16, 2021
5 cases
Recall Profile & Regulatory Data
Event ID
87907
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Fresenius Medical Care Holdings, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Termination Date
Sep 17, 2021
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
Batch or Lot Expiration Information
Lot# : 20SU02032, Exp. date July 2022
Affected Packages Involved in this Recall
49230-206-92Product
49230-206-94Product
49230-206-95Product
49230-209-92Product
49230-209-94Product
49230-209-95Product
49230-212-92Product
49230-212-94Product
49230-212-95Product
Class III Terminated
Temperature Abuse: Product exposed to temperature outside specified limits.
Apr 28, 2021
Jun 16, 2021
672 cases
Recall Profile & Regulatory Data
Event ID
87907
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Fresenius Medical Care Holdings, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Termination Date
Sep 17, 2021
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
Batch or Lot Expiration Information
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
Affected Packages Involved in this Recall
49230-206-20Product
49230-206-30Product
49230-206-32Product
49230-206-50Product
49230-206-60Product
49230-206-62Product
49230-206-52Product
49230-209-23Product
49230-209-30Product
49230-209-32Product
49230-209-50Product
49230-209-60Product
49230-209-62Product
49230-209-52Product
49230-212-23Product
49230-212-30Product
49230-212-32Product
49230-212-50Product
49230-212-60Product
49230-212-62Product
49230-212-52Product
49230-0209-23Product
April 2021 Class II Recall: Labeling; Label Mix-up; 4.25% DEXTROSE bag was found inside a 1.5% DEXTROSE box.
Recall Number
Class II Terminated
Labeling; Label Mix-up; 4.25% DEXTROSE bag was found inside a 1.5% DEXTROSE box.
Apr 14, 2021
May 26, 2021
709 cases
Recall Profile & Regulatory Data
Event ID
87809
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Fresenius Medical Care, North America
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA Nationwide
Termination Date
Apr 05, 2022
Product Description
Delflex Peritoneal Dialysis Solution with 1.5% Dextrose, LM/LC, packaged in a case containing 2 x 6 Liter bags, Rx only, NDC 49230-206-60, Fresenius Medical Care North America, Waltham, MA 02451
Batch or Lot Expiration Information
Lot# 20SU03019, Exp 6/2022
Affected Packages Involved in this Recall
49230-206-20Product
49230-206-30Product
49230-206-32Product
49230-206-50Product
49230-206-60Product
49230-206-62Product
49230-206-52Product
49230-209-23Product
49230-209-30Product
49230-209-32Product
49230-209-50Product
49230-209-60Product
49230-209-62Product
49230-209-52Product
49230-212-23Product
49230-212-30Product
49230-212-32Product
49230-212-50Product
49230-212-60Product
49230-212-62Product
49230-212-52Product
Class II Terminated
Lack of Assurance of Sterility: Leakage of the peritoneal dialysis (PD) solution bag.
Dec 20, 2017
Mar 28, 2018
3,734 cases
Recall Profile & Regulatory Data
Event ID
79403
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Fresenius Medical Care Renal Therapies Group, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed throughout the United States to patients and clinics.
Termination Date
Feb 14, 2019
Product Description
DELFLEX Peritoneal Dialysis Solution, 2.5% Low Mg/Low Ca Single Bag, packaged in a) 3L (4 pack, NDC 49230-209-30), b) 2 L(6 pack NDC 49230-209-23), Rx only, Fresenius Medical Care NA, Waltham, MA 02451.
Batch or Lot Expiration Information
Lot# : a) 17KU03006, 7KU03007; b) 17KU03004, 17KU03005, Exp.08/2019
Affected Packages Involved in this Recall
49230-206-20Product
49230-206-30Product
49230-206-32Product
49230-206-50Product
49230-206-60Product
49230-206-62Product
49230-206-52Product
49230-209-23Product
49230-209-30Product
49230-209-32Product
49230-209-50Product
49230-209-60Product
49230-209-62Product
49230-209-52Product
49230-212-23Product
49230-212-30Product
49230-212-32Product
49230-212-50Product
49230-212-60Product
49230-212-62Product
49230-212-52Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
