Home / Recalls / Baxter Healthcare Corp. / Z-0109-2014

Z-0109-2014 Class II Terminated

Recalled by Baxter Healthcare Corp. — Deerfield, IL

FDA device recall Z-0109-2014 was initiated by Baxter Healthcare Corp. on Aug 30, 2013 and is designated Class II. Reason for recall: Potential tears in the pouch of six lots of Vented Spike Adapter Product Code 2C0471 The recall status is terminated (terminated Apr 19, 2017). Affected quantity: 49,344 units.

Recall Details

Product Type: Devices
Report Date: Nov 6, 2013
Initiation Date: Aug 30, 2013
Termination Date: Apr 19, 2017
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 49,344 units

Product Description

Vented Spike Adapter Product Code 2C0471, Sterile, nopyrogenic. Manufactured by an affiliate of Baxter Healthcare Corporation, Clintec Nutrition Division, Deerfield IL 60015 USA. An IV transfer device, used to transfer fluids in pharmacy compounding system.

Reason for Recall

Potential tears in the pouch of six lots of Vented Spike Adapter Product Code 2C0471

Distribution Pattern

Nationwide distribution.

Code Information

R13D09024, R13D09107, R13D12101, R13D17068, R13D18066, R13D20070

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-0109-2014
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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