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Z-1565-2013 Class II Terminated

Recalled by Baxter Healthcare Corp. — Deerfield, IL

FDA device recall Z-1565-2013 was initiated by Baxter Healthcare Corp. on May 21, 2013 and is designated Class II. Reason for recall: leaking pouches The recall status is terminated (terminated Jul 14, 2016). Affected quantity: 629,280 units.

Recall Details

Product Type: Devices
Report Date: Jul 3, 2013
Initiation Date: May 21, 2013
Termination Date: Jul 14, 2016
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 629,280 units

Product Description

Baxter, MiniCap with Povidone-Iodine solution, 5C4466P, Baxter Healthcare Corporation. For dialysis. Intended to isolate the Easy-Lock connector of the solution transfer set.

Reason for Recall

leaking pouches

Distribution Pattern

Nationwide Distribution.

Code Information

Lot Number GD893891

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-1565-2013
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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