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

FDA device recall Z-0392-2014 · posted 2013-11-26 · Terminated

Recall details

Recalling firm

Baxter Healthcare Corp.

Reason for recall

Incomplete foil seal on one lot of sterile product.

Action taken

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.

Root cause

Packaging process control

Status

Terminated

Product code

LHI

Quantity affected

38,400 units

Distribution

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

Date initiated

2013-09-25

Date posted

2013-11-26

Date terminated

2014-07-22

Location

Deerfield, IL

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