Reported Jul 24, 2013 · Terminated
Safety Lancets - Odyssey, Button Activated; Tri- Bevel Tip for Virtually Painless Sampling; Needle automatically…
KooJoo Trading Company
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: KooJoo Trading Company · 116-7 Songma-li, Daegoj-myun · Gimpo City, Gyeongki-Do, N/A · N/A
Is this the product you have?
- 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.
- Lot codes and dates
Lot # HBM1303-4886Exp 3/6/2016Lot# HBM1303-4886Exp 3.6 to 3/21/2016Lot# HBM1201-02Exp 1/16/2015Lot# HBM1203-02Exp 4/5/2015
- Amount recalled
- 7, 712, 000 pieces (1928 cartons)
Where it was sold
Why it was recalled
Lancets were not sterilized within the dose range established by sterilization validation.
This product could cause temporary or reversible health problems — stop using it.
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