Extended Tip Applicator recalled for endotoxin and sterility issues
Integra LifeSciences recalls Extended Tip Applicators due to potentially out-of-specification endotoxin levels and lack of sterility assurance, affecting 6,216 units distributed nationwide 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: FDA Class I classification mandates a minimum severity score of 4 (Severe). The device contains potentially out-of-specification endotoxins and lacks sterility assurance, presenting a significant risk to patients, despite no reported illnesses in the source text.
Plain-English summary
Integra LifeSciences Corp. (NeuroSciences) is recalling the Extended Tip Applicator, 8CM, Box of 5 (Model 205108) due to potentially out-of-specification levels of endotoxins and lack of sterility assurance. These quality issues could compromise the sterility and safety of the medical device.
The recall affects 6,216 units distributed nationwide throughout the United States 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 numerous European countries. All lots of the product are affected.
Healthcare facilities should immediately cease use of affected devices and contact Integra LifeSciences for replacement or further guidance. Patients or healthcare providers with questions about potential exposure should contact their medical facility or the manufacturer.
The recalled product
- Product
- Extended Tip Applicator, 8CM, Box of 5.
- Manufacturer
- Integra LifeSciences Corp. (NeuroSciences)
- Category
- Medical Device
- Hazard
- endotoxins
- sterility-failure
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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