Device product
One Step Sterile Lancet for Single Use (3 sizes): 06949517008861 30g 06949517008854 28g 06949517008847 23g The Lancing System is intended for the hygienic collection of capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the palm, the upper arm, and the forearm.
Z-0226-2026
Product summary
- Event
- Event 97350
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 4,661 lancets
- Official record key
device-enforcement:Z-0226-2026
Official wording
Reason: Due to incorrect/lack of Unique Device Identifier (UDI) codes.
Code information: UDI-DI code / Size: 06949517008861 / 30g Lot Number: 2312290802 06949517008854 / 28g Lot Number: 2406310201 06949517008847 / 23g Lot Number: 2406310201
Distribution pattern: U.S.: Nation-wide distributed thru Amazon U.S. States include: AZ, CA, FL, IL, NC, NM, NY, TN, TX, and VA. O.U.S.: N/A
Derived failure modes
-
Unknown
Due to incorrect/lack of Unique Device Identifier (UDI) codes.