Device product
Safety Lancets - Odyssey, Button Activated; Tri- Bevel Tip for Virtually Painless Sampling; Needle automatically retracts, No lancing device required. 26G - Single Use Only, Made In Korea Distributed by Hummingbird Medical, Savannah, GA 100 count Boxes; 40 boxes per case Blood collection by penetrating skin with needle.
Z-1729-2013
Product summary
- Event
- Event 65664
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7, 712, 000 pieces (1928 cartons)
- Official record key
device-enforcement:Z-1729-2013
Official wording
Reason: Lancets were not sterilized within the dose range established by sterilization validation.
Code information: Lot # HBM1303-4886, Exp 3/6/2016; Lot# HBM1303-4886, Exp 3.6 to 3/21/2016; Lot# HBM1201-02, Exp 1/16/2015; Lot# HBM1203-02, Exp 4/5/2015
Distribution pattern: US Distribution GA only.
Derived failure modes
-
Unknown
Lancets were not sterilized within the dose range established by sterilization validation.