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Z-1945-2014 Class II Terminated

Recalled by Baxter Healthcare Corp. — Deerfield, IL

FDA device recall Z-1945-2014 was initiated by Baxter Healthcare Corp. on Jul 8, 2013 and is designated Class II. Reason for recall: the white printed paper layer on the pouch packaging may not be fully adhered to the pouch foil layer. The upper paper layer may serve as a protective barrier and help support overall packaging. The recall status is terminated (terminated Jun 30, 2014). Affected quantity: 20,940 units.

Recall Details

Product Type: Devices
Report Date: Jul 9, 2014
Initiation Date: Jul 8, 2013
Termination Date: Jun 30, 2014
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 20,940 units

Product Description

Baxter, MiniCap with Povidone-Iodine solution, 5C4466P. For dialysis.

Reason for Recall

the white printed paper layer on the pouch packaging may not be fully adhered to the pouch foil layer. The upper paper layer may serve as a protective barrier and help support overall packaging.

Distribution Pattern

Distributed in the states of AR, TN MO, KS, TX, MS, and AL.

Code Information

Lot Numbers: GD894535, GD894550

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-1945-2014
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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