Recall Z-1729-2013— KooJoo Trading Company
Class II · Terminated
Class II FDA medical device recall by KooJoo Trading Company, initiated 2013-07-03, terminated 2015-03-13. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Lancets were not sterilized within the dose range established by sterilization validation..
- Recalling firm
- KooJoo Trading Company
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-07-03
- Terminated
- 2015-03-13
- Firm location
- Gimpo City, Gyeongki-Do, N/A, Korea, Republic Of (South)
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.