June 2024 FDA Recall Delflex by Fresenius Medical Care Holdings, Inc.
D-0608-2024 - This product is being recalled due to the tube weld failure presents itself as a slow leak and can be difficult to detect.
This Class II drug recall was voluntarily initiated by Fresenius Medical Care Holdings, Inc. on June 18, 2024 for the product Delflex. The FDA reported the reason for recall as this product is being recalled due to the tube weld failure presents itself as a slow leak and can be difficult to detect.. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0608-2024
This product is being recalled due to the tube weld failure presents itself as a slow leak and can be difficult to detect.
06-18-2024
07-24-2024
183 cases
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
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
