Dianeal PD-2 Peritoneal Dialysis Solution with 1.5% Dextrose, 6000 mL Ambu-Flex II container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product Code L5B9710, NDC 0941-0411-11
Reported: May 7, 2014 Initiated: February 11, 2014 #D-1276-2014
Product Description
Dianeal PD-2 Peritoneal Dialysis Solution with 1.5% Dextrose, 6000 mL Ambu-Flex II container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product Code L5B9710, NDC 0941-0411-11
Reason for Recall
Non-Sterility: Complaints of leaks and particulate matter identified as mold in the solution bag and the overpouch.
Details
- Recalling Firm
- Baxter Healthcare Corp.
- Units Affected
- 27,169 containers
- Distribution
- Nationwide.
- Location
- Deerfield, IL
Frequently Asked Questions
What product was recalled? ▼
Dianeal PD-2 Peritoneal Dialysis Solution with 1.5% Dextrose, 6000 mL Ambu-Flex II container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product Code L5B9710, NDC 0941-0411-11. Recalled by Baxter Healthcare Corp.. Units affected: 27,169 containers.
Why was this product recalled? ▼
Non-Sterility: Complaints of leaks and particulate matter identified as mold in the solution bag and the overpouch.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 7, 2014. Severity: Critical. Recall number: D-1276-2014.
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