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KooJoo Trading Company recalls Safety Lancets - Odyssey, Button Activated; Tri- Bevel Tip for Virtually Painless Sampling; Needle automatically retrac
Recalled July 24, 2013 · FDA recall Z-1729-2013 · KooJoo Trading
Hazard
Lancets were not sterilized within the dose range established by sterilization validation. · FDA Class II
Units
7, 712, 000 pieces (1928 cartons)
Sold at
US Distribution GA only.
Description
Lancets were not sterilized within the dose range established by sterilization validation.
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.
Manufacturer(s)
KooJoo Trading Company
Made in
Korea, Republic Of (South)
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →