Z-0174-2009

Premier Value Lancing Device. UPC Code: 840986016707, The Package Includes: 1 Lancing Device, 1 Clear Cap and...

Name: Z-0174-2009 Premier Value Lancing Device. UPC Code: 840986016707, The Package Includes: 1 Lancing Device, 1 Clear Cap and...
Creator: Facet Technologies
Published: 2008-07-18
License: https://open.fda.gov/license/

Facet Technologies, LLC. / initiated 2008-07-18 / Terminated / root cause: labeling and UDI

FDA source

Facet Technologies began a recall of Premier Value Lancing Device. UPC Code: 840986016707, The Package Includes: 1 Lancing Device, 1 Clear Cap and 5 Premier Value Ultra Thin Lancets, Distributed... on 2008-07-18. The reason FDA records is "The Alternate Site Cap was not included in the package as indicated on the labeling". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0174-2009
Status: Terminated
Initiated: 2008-07-18
Posted: 2008-10-27
Terminated: 2009-08-24
Recalling firm: Facet Technologies, LLC.
Product: 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.
Product code: FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
Reason for recall: The Alternate Site Cap was not included in the package as indicated on the labeling.
Root cause tag: labeling and UDI
FDA 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 in commerce: 2976 units
Distribution: Nationwide--GA and FL.
Product codes and lots: Lot Numbers: M057030, and M057022; Unit numbers: L339011, L339011, L339011, and L339011,

Product code FMK

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)