Extended Tip Applicator 8CM Recalled for Endotoxin and Sterility Defects
Integra LifeSciences is recalling Extended Tip Applicator 8CM devices (212 units) due to endotoxin contamination and lack of sterility assurance. The FDA Class I recall affects devices distributed in the US and internationally.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: This FDA Class I recall involves endotoxin contamination and loss of sterility assurance on medical devices. FDA Class I recalls indicate a condition where exposure to the affected product can cause serious injury or death.
Plain-English summary
Integra LifeSciences Corp. (NeuroSciences) is recalling Extended Tip Applicator 8CM devices distributed in boxes of one unit. The recall affects all lots (Model/Catalog Number 201108; UDI 10381780000167) with 212 units identified.
The devices contain potentially out-of-specification levels of endotoxins and lack adequate sterility assurance, compromising their safety for medical use.
The recalled devices have been distributed nationwide in the United States and internationally to multiple countries including Canada, Japan, Australia, New Zealand, Taiwan, Mexico, and Colombia, as well as numerous countries across Europe, Asia, the Middle East, Africa, and Latin America.
Healthcare facilities and other users who have received these devices should contact Integra LifeSciences for further instructions and guidance on handling the recalled units.
The recalled product
- Product
- Extended Tip Applicator 8CM, Box of 1.
- Manufacturer
- Integra LifeSciences Corp. (NeuroSciences)
- Category
- Medical Device
- Hazard
- endotoxin
- 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: 201108
- UDI 10381780000167
- All Lots.
Distribution
Distributed nationwide across the United States.
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