FDA recall D-0351-2019

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.

Reason for recall

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

Distribution

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

Key facts

Status

Terminated

Initiation date

2019-01-02

Report date

2019-01-16

Termination date

2020-04-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0351-2019