Z-1729-2013 Class II Terminated
FDA device recall Z-1729-2013 was initiated by KooJoo Trading Company on July 3, 2013 and is designated Class II. Reason for recall: Lancets were not sterilized within the dose range established by sterilization validation. The recall status is terminated (terminated March 13, 2015). Affected quantity: 7, 712, 000 pieces (1928 cartons).
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