Baxter Healthcare Corporation recalls Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose, 2000 mL UltraBag container bag, Rx only
Recalled January 16, 2019 · FDA recall D-0351-2019 · Baxter Healthcare
Hazard
Lack of Assurance of Sterility: Confirmed customer complaints for leaks on the tubing. · FDA Class II
Units
29,370 bags
Sold at
Nationwide in the USA to Wholesaler/Distributors, Healthcare Facilities and Home Patients.
Description
Lack of Assurance of Sterility: Confirmed customer complaints for leaks on the tubing.
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.
Manufacturer(s)
Baxter Healthcare Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →