December 2017 FDA Recall Delflex by Fresenius Medical Care Renal Therapies Group, Llc
D-0604-2018 - Lack of Assurance of Sterility
This Class II drug recall was voluntarily initiated by Fresenius Medical Care Renal Therapies Group, Llc on December 20, 2017 for the product Delflex. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed in Product was distributed throughout the United States to patients and clinics. and the recall is currently terminated.
Recall Number: D-0604-2018
Lack of Assurance of Sterility: Leakage of the peritoneal dialysis (PD) solution bag.
12-20-2017
03-28-2018
3,734 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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Fresenius Medical Care Renal Therapies Group, LLC
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.
Product was distributed throughout the United States to patients and clinics.
02-14-2019
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
