Premier Value Lancing Device. UPC Code: 840986016707, The Package Includes: 1 Lancing Device, 1 Clear Cap and 5 Premier Value Ultra Thin Lancets, Distributed by: Chain Drug Consortium, LLC, Boca Raton, FL 33431. Lancing Device intended to be used by diabetes patients that require a drop of capillary blood for testing.
FDA Recall Z-0174-2009 · Posted 2008-10-27
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Recalling FirmFacet Technologies
Recall StatusTerminated
Product CodeFMK
Date Initiated2008-07-18
Date Terminated2009-08-24
Product Quantity2976 units
Reason for Recall
The Alternate Site Cap was not included in the package as indicated on the labeling.
Firm Action
The consignees were notified by letter on/about 7/18/2008. The Return Material Authorization number was communicated to the customer. They were asked to place the items on hold and Can Am will obtain any quantities. The Returned Product Mechanics Process will: Inventory will be sent back to Facet in two stages, Inventory on hand at Cimetra will be sent back to Facet, Inventory received back from customers will be sent back to Facet in one shipment 30-60 days after notice. Inventory received back after this second shipment will be destroyed.
Root Cause
Error in labeling
Distribution Pattern
Nationwide--GA and FL.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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