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D-1610-2014 Class I Terminated

Recalled by Baxter Healthcare Corp. — Deerfield, IL

FDA drug recall D-1610-2014 was initiated by Baxter Healthcare Corp. on Aug 7, 2014 and is designated Class I. Reason for recall: Presence of Particulate Matter: particulate matter was found during the manufacturing process. The recall status is terminated (terminated Apr 28, 2017). Affected quantity: 50,530 bags.

Recall Details

Product Type: Drugs
Report Date: Oct 8, 2014
Initiation Date: Aug 7, 2014
Termination Date: Apr 28, 2017
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 50,530 bags

Product Description

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.

Reason for Recall

Presence of Particulate Matter: particulate matter was found during the manufacturing process.

Distribution Pattern

Nationwide

Code Information

Lot #: C940700, C940841, Exp 05/16

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-1610-2014
openFDA file date: Oct 27, 2026
Loaded by RegDataLab: Oct 29, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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