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Z-1269-2015 Class II

Recalled by Baxter Healthcare Corp. — Deerfield, IL

FDA device recall Z-1269-2015 was initiated by Baxter Healthcare Corp. on Jan 22, 2015 and is designated Class II. Reason for recall: Product may have separating or protruding sponges Affected quantity: 4,391,520 units.

Recall Details

Product Type: Devices
Report Date: Mar 25, 2015
Initiation Date: Jan 22, 2015
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 4,391,520 units

Product Description

MiniCap with Povidone-Iodine Solution, item number 5C4466P, for hemodialysis.

Reason for Recall

Product may have separating or protruding sponges

Distribution Pattern

Worldwide Distribution - Nationwide Distribution and to the countries of : Canada, Austria, Norway, Portugal, Saudi Arabia and Spain.

Code Information

Lot Numbers: GD896845, Exp. 10/2015; GD897371, Exp. 01/2016; GD896936, Exp. 10/2015; GD897124, Exp. 11/2015; GD897165, Exp. 12/2015; GD897157, Exp. 12/2015; GD896944, Exp. 11/2015; GD896837, Exp. 10/2015

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-1269-2015
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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