FDAFDA · Food and drugs·Recall number Z-1729-2013
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.
Published July 24, 2013 · Recall initiated: July 3, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lancets were not sterilized within the dose range established by sterilization validation.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- KooJoo Trading Company
- Distributor
- US Distribution GA only.
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Korea, Republic Of (South)
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