Dianeal Low Calcium Peritoneal Dialysis Solution with 1 recalled over sterility concerns

Recall date

January 2, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Baxter Healthcare Corporation recalls Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose, 2000 mL UltraBag container bag, Rx onl…

Recall number

D-0351-2019

FDA classification

Class II

Brand / firm

Baxter Healthcare Corporation

Sold / distributed

Nationwide in the USA to Wholesaler/Distributors, Healthcare Facilities and Home Patients.

Why it was recalled

Lack of Assurance of Sterility: Confirmed customer complaints for leaks on the tubing.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.