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.
Reported: January 16, 2019 Initiated: January 2, 2019 #D-0351-2019
Product Description
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.
Details
- Recalling Firm
- Baxter Healthcare Corporation
- Units Affected
- 29,370 bags
- Distribution
- Nationwide in the USA to Wholesaler/Distributors, Healthcare Facilities and Home Patients.
- Location
- Deerfield, IL
Frequently Asked Questions
What product 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.. Recalled by Baxter Healthcare Corporation. Units affected: 29,370 bags.
Why was this product recalled? ▼
Lack of Assurance of Sterility: Confirmed customer complaints for leaks on the tubing.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 16, 2019. Severity: Moderate. Recall number: D-0351-2019.
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