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Z-0392-2014 Class II Terminated

Recalled by Baxter Healthcare Corp. — Deerfield, IL

FDA device recall Z-0392-2014 was initiated by Baxter Healthcare Corp. on Sep 25, 2013 and is designated Class II. Reason for recall: Incomplete foil seal on one lot of sterile product. The recall status is terminated (terminated Jul 22, 2014). Affected quantity: 38,400 units.

Recall Details

Product Type: Devices
Report Date: Dec 4, 2013
Initiation Date: Sep 25, 2013
Termination Date: Jul 22, 2014
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 38,400 units

Product Description

Baxter, VIAL-MATE Adaptor, 2B8071, Rx Only, STERILE R, Baxter Healthcare Corporation, Deerfield, IL 30015 USA The VIAL-MATE is reconstitution device labeled for use with 20 mm drug vials and 50mL, 100mL, and 250mL Single Pack Mini Bags.

Reason for Recall

Incomplete foil seal on one lot of sterile product.

Distribution Pattern

Nationwide Distribution including WV, KY, IA, AR, OH, IL, IN, MI, KS, TN, WI, MN, MO.

Code Information

Lot Number GR13G23028

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-0392-2014
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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