January 2019 FDA Recall Dianeal Low Calcium With Dextrose by Baxter Healthcare Corporation
D-0351-2019 - Lack of Assurance of Sterility
This Class II drug recall was voluntarily initiated by Baxter Healthcare Corporation on January 2, 2019 for the product Dianeal Low Calcium With Dextrose. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0351-2019
Lack of Assurance of Sterility: Confirmed customer complaints for leaks on the tubing.
01-02-2019
01-16-2019
29,370 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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Baxter Healthcare Corporation
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 in the USA to Wholesaler/Distributors, Healthcare Facilities and Home Patients.
04-29-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose, 2000 mL UltraBag container bag, Rx only; Baxter Healthcare Corporation, Deerfield, IL 60015; Product Code 5B9766, NDC 0941-0424-52.
Batch or Lot Expiration Information
Lot# : Y281477, Expiry: 02/2020
