Class I
Terminated
Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose, 5000 mL Ambu-Flex II container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015; Product Code L5B5202, NDC 0941-0457-05.
This recall has been terminated (originally issued October 8, 2014).
- Company
- Baxter Healthcare Corp.
- Recall Initiated
- August 7, 2014
- Posted
- October 8, 2014
- Recall Number
- D-1610-2014
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 50,530 bags
- Firm Location
- Deerfield, IL, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Presence of Particulate Matter: particulate matter was found during the manufacturing process.
Distribution
Nationwide
Lot / Code Info
Lot #: C940700, C940841, Exp 05/16
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