Extended Tip Applicator 8CM distributed by Integra LifeSciences recalled nationwide
Integra LifeSciences is recalling Extended Tip Applicator 8CM devices due to potentially out-of-specification endotoxin levels and lack of sterility assurance. The recall affects 6,216 units distributed across the US and internationally.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this as a Class I recall, which per the rubric requires a minimum severity score of 4. The hazard involves lack of sterility assurance and out-of-specification endotoxin levels on a medical device distributed nationwide and internationally, meeting the threshold for a Severe classification.
Plain-English summary
Integra LifeSciences Corp. (NeuroSciences) is recalling the Extended Tip Applicator, 8CM, Box of 5 (Model/Catalog Number 205108) due to devices containing potentially out-of-specification levels of endotoxins and lack of sterility assurance. The recall affects 6,216 units.
The affected devices were distributed domestically nationwide and internationally to Canada, Japan, Australia, New Zealand, Taiwan, Mexico, Colombia, Dominican Republic, Singapore, Mongolia, Hong Kong, Chile, Argentina, Puerto Rico, El Salvador, Guatemala, South Korea, Peru, Costa Rica, Panama, and various European countries including Austria, Belgium, Cyprus, Czechia, France, Georgia, Germany, Greece, Hungary, Ireland, Italy, Malta, Netherlands, Portugal, Romania, Spain, Sweden, and Switzerland, as well as Iran, Jordan, Nigeria, Palestine, Saudi Arabia, South Africa, and Turkey.
All lots of the Extended Tip Applicator bearing UDI 10381780000143 are affected by this recall. Healthcare facilities and users should discontinue use of affected devices and contact Integra LifeSciences for further instructions regarding product handling and replacement options.
The recalled product
- Product
- Extended Tip Applicator, 8CM, Box of 5.
- Manufacturer
- Integra LifeSciences Corp. (NeuroSciences)
- Category
- Medical Device
- Hazard
- endotoxin
- sterility-assurance
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 (3)
- Model/Catalog Number: 205108
- UDI: 10381780000143
- All Lots.
Distribution
Distributed nationwide across the United States.
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