Z-1729-2013 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 24, 2013
- Initiation Date
- July 3, 2013
- Termination Date
- March 13, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7, 712, 000 pieces (1928 cartons)
Product Description
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.
Reason for Recall
Lancets were not sterilized within the dose range established by sterilization validation.
Distribution Pattern
US Distribution GA only.
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