December 2023 FDA Recall Delflex by Fresenius Medical Care Holdings, Inc.
D-0218-2024 - Lack of Sterility Assurance
This Class II drug recall was voluntarily initiated by Fresenius Medical Care Holdings, Inc. on December 28, 2023 for the product Delflex. The FDA reported the reason for recall as lack of sterility assurance. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0218-2024
Lack of Sterility Assurance
12-28-2023
01-10-2024
69,590 bags
Recall Profile & Regulatory Data
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Fresenius Medical Care Holdings, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide within the United States
Product Description About Product Description
Full technical description of the product.
Full technical description of 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.
Batch or Lot Expiration Information
Lot# Part Number: 077-60621
Lot# : 23JK02010, Exp. Date 1/31/2025
