Recall Enforment Report D-0218-2024

Drug Recall Enforcement Report Class II voluntary initiated by Fresenius Medical Care Holdings, Inc., originally initiated on 12-28-2023 for the product 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. The product was recalled due to lack of sterility assurance. The product was distributed nationwide and the recall is currently ongoing.

Field Name	Field Value
Event ID	93690 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0218-2024 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	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.
Reason For Recall	Lack of Sterility Assurance What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	69,590 bags 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	01-10-2024
Recall Initiation Date	12-28-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of 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	Part Number: 077-60621, Lot #: 23JK02010, Exp. Date 1/31/2025 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	Ongoing

Recalled Products