FDAFDA · Food and drugs·Recall number D-1276-2014
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
Published May 7, 2014 · Recall initiated: February 11, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Non-Sterility: Complaints of leaks and particulate matter identified as mold in the solution bag and the overpouch.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- DIANEAL LOW CALCIUM WITH DEXTROSE
- Manufacturer
- Baxter Healthcare Corp.
- Distributor
- Nationwide.
- Lot
- Lot number: C903799, Exp 05/15
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
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