Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose, For Intraperitoneal Administration Only, 6000 mL per bag, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA. NDC: 0941-0457-01
Reported: July 17, 2024 Initiated: June 17, 2024 #D-0587-2024
Product Description
Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose, For Intraperitoneal Administration Only, 6000 mL per bag, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA. NDC: 0941-0457-01
Reason for Recall
Lack of Assurance of Sterility: Potential presence of leaks originating from the Connector Assembly component.
Details
- Recalling Firm
- Baxter Healthcare Corporation
- Units Affected
- 6,874 bags
- Distribution
- US Nationwide, Canada
- Location
- Deerfield, IL
Frequently Asked Questions
What product was recalled? ▼
Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose, For Intraperitoneal Administration Only, 6000 mL per bag, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA. NDC: 0941-0457-01. Recalled by Baxter Healthcare Corporation. Units affected: 6,874 bags.
Why was this product recalled? ▼
Lack of Assurance of Sterility: Potential presence of leaks originating from the Connector Assembly component.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 17, 2024. Severity: Moderate. Recall number: D-0587-2024.
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