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Z-2074-2014 Class II Terminated

Recalled by Baxter Healthcare Corp. — Deerfield, IL

FDA device recall Z-2074-2014 was initiated by Baxter Healthcare Corp. on Jun 17, 2014 and is designated Class II. Reason for recall: Inadequate iodine and packaging related defects. The recall status is terminated (terminated Apr 3, 2015). Affected quantity: 585,360 units.

Recall Details

Product Type: Devices
Report Date: Jul 23, 2014
Initiation Date: Jun 17, 2014
Termination Date: Apr 3, 2015
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 585,360 units

Product Description

Baxter MiniCap with Povidone-Iodine Solution, 5C4466P, Baxter Healthcare Corporation. For dialysis.

Reason for Recall

Inadequate iodine and packaging related defects.

Distribution Pattern

Distributed USA (nationwide) and Canada.

Code Information

GD895771

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-2074-2014
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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