Extended Tip Applicator Recalled for Potential Sterility and Endotoxin Issues
Integra LifeSciences has recalled approximately 2,524 Extended Tip Applicators due to potentially out-of-specification endotoxin levels and lack of sterility assurance. The devices were distributed nationwide in 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: This is an FDA Class I recall. Per the severity rubric, FDA Class I recalls cannot be scored lower than 4 (Severe). While no illnesses or injuries have been reported, the out-of-specification endotoxins and lack of sterility assurance in this medical device meet the Class I classification threshold.
Plain-English summary
Integra LifeSciences Corp. (NeuroSciences) is recalling approximately 2,524 units of Extended Tip Applicators, 15 CM, Box of 5 (Model/Catalog Number 205115). The devices were distributed nationwide throughout the United States and to numerous countries including Canada, Japan, Australia, New Zealand, Taiwan, Mexico, and various nations in Europe and Asia.
The devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance. These conditions are the basis for the recall.
Healthcare facilities and practitioners who received these devices should discontinue use immediately and contact Integra LifeSciences Corp. for return or replacement instructions. Patients who may have received treatment using these devices should contact their healthcare provider.
The recalled product
- Product
- Extended Tip Applicator, 15 CM, Box of 5.
- 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: 205115
- UDI: 10381780000150
- All Lots.
Distribution
Distributed nationwide across the United States.
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