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Z-0194-2016 Class II Terminated

Recalled by Baxter Healthcare Corp. — Deerfield, IL

FDA device recall Z-0194-2016 was initiated by Baxter Healthcare Corp. on Oct 6, 2015 and is designated Class II. Reason for recall: Leakage from the inlet port of the 15L Cycler Drainage Bags. The recall status is terminated (terminated Jun 27, 2016). Affected quantity: 19,440 units.

Recall Details

Product Type: Devices
Report Date: Nov 11, 2015
Initiation Date: Oct 6, 2015
Termination Date: Jun 27, 2016
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 19,440 units

Product Description

Baxter 15L Cycler Drainage Bag Sterile, nonpyrogenic fluid path

Reason for Recall

Leakage from the inlet port of the 15L Cycler Drainage Bags.

Distribution Pattern

US Distribution and Internationally to Canada.

Code Information

H15C11095

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-0194-2016
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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