FDA-Device2013-07-24Class II
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.
KooJoo Trading Company
Hazard
Lancets were not sterilized within the dose range established by sterilization validation.
Sold states
US Distribution GA only.
Affected count
7, 712, 000 pieces (1928 cartons)
Manufactured in
116-7 Songma-li, Daegoj-myun, N/A, Gimpo City, Gyeongki-Do, N/A, Korea, Republic Of (South)
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1729-2013Don't want to check this manually?
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