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.
FDA Recall Z-0392-2014 · Posted 2013-11-26
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Recalling FirmBaxter Healthcare Corp.
Recall StatusTerminated
Product CodeLHI
Date Initiated2013-09-25
Date Terminated2014-07-22
Product Quantity38,400 units
Reason for Recall
Incomplete foil seal on one lot of sterile product.
Firm 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.
Root Cause
Packaging process control
Distribution Pattern
Nationwide Distribution including WV, KY, IA, AR, OH, IL, IN, MI, KS, TN, WI, MN, MO.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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