FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-0174-2009
- Recalling firm
- Facet Technologies
- 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.
- Status
- Terminated
- Initiated
- 2008-07-18
- Posted
- 2008-10-27
- Terminated
- 2009-08-24
- 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.
- Lot, serial or model codes
- Lot Numbers: M057030, and M057022; Unit numbers: L339011, L339011, L339011, and L339011,
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FMK
- Firm FEI
- 3011617315
- Firm city
- McDonough
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28