Z-0392-2014Class II

Baxter, VIAL-MATE Adaptor, 2B8071, Rx Only, STERILE R, Baxter Healthcare Corporation, Deerfield, IL 30015 USA...

Name: Z-0392-2014 Baxter, VIAL-MATE Adaptor, 2B8071, Rx Only, STERILE R, Baxter Healthcare Corporation, Deerfield, IL 30015 USA...
Creator: Baxter Healthcare Corp.
Published: 2013-09-25
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2013-09-25 / Terminated / root cause: packaging

FDA source

Baxter Healthcare Corp. began a recall of Baxter, VIAL-MATE Adaptor, 2B8071, Rx Only, STERILE R, Baxter Healthcare Corporation, Deerfield, IL 30015 USA The VIAL-MATE is reconstitution device labeled... on 2013-09-25. FDA classified it as Class II and gives the reason as "Incomplete foil seal on one lot of sterile product". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0392-2014
Classification: Class II
Status: Terminated
Initiated: 2013-09-25
Posted: 2013-11-26
Terminated: 2014-07-22
Recalling firm: Baxter Healthcare Corporation
Product: 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.
Product code: LHI Set, I.V. Fluid Transfer
Reason for recall: Incomplete foil seal on one lot of sterile product.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Baxter Healthcare sent an Urgent Product Recall letter dated September 25, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to locate and remove all affected product from their facility, contact Baxter's Center for Service at 1-888-229-0001 to arrange for return and credit. Complete the attached Customer Reply Form and return it to Baxter by fax or email. Customers with questions were instructed to call 1-800-422-9837. For questions regarding this recall call 224-948-4770.
Quantity in commerce: 38,400 units
Distribution: Nationwide Distribution including WV, KY, IA, AR, OH, IL, IN, MI, KS, TN, WI, MN, MO.
Product codes and lots: Lot Number GR13G23028

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0392-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0392-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-04	2013-11-26

Product code LHI

K973654Class IIVial-Mate Reconstitution Device (2B8071)Baxter Healthcare Corp / cleared 1997-10-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)