Recall Z-0174-2009 ยท FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
Facet Technologies
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.
| Date | Oct 27, 2008 (initiated Jul 18, 2008) |
| Status | Terminated |
| Reason | The Alternate Site Cap was not included in the package as indicated on the labeling. |
| Root cause | Error in labeling |
| 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. |
| Quantity | 2976 units |
| Distribution | Nationwide--GA and FL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.