KooJoo Trading Company Recalls Unsterilized Safety Lancets
KooJoo Trading Company is recalling specific lots of Odyssey safety lancets because they were not sterilized within the established validation dose range.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where the sterilization process was not validated, creating a risk of infection or injury. This fits the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
KooJoo Trading Company is recalling approximately 7,712,000 pieces of Odyssey safety lancets. The product is a button-activated, single-use lancet with a 26G needle that automatically retracts, distributed by Hummingbird Medical in Savannah, Georgia. The recall involves specific lots with expiration dates ranging from January 2015 to March 2016.
The recall was initiated because the lancets were not sterilized within the dose range established by sterilization validation. This means the sterilization process may not have been effective for these specific units. The affected products were distributed only in the state of Georgia.
Consumers who have these specific lots of lancets should stop using them immediately. The source text does not provide specific instructions for disposal or return, but users should contact their healthcare provider or the distributor for guidance on how to handle the recalled items.
The recalled product
- 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…
- Manufacturer
- KooJoo Trading Company
- Category
- Medical Device — Lancets
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- 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
Distribution
Distribution scope not specified by the agency.
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