Extended Tip Applicator 8CM medical devices recalled due to sterility concerns
Integra LifeSciences is recalling Extended Tip Applicator 8CM devices nationwide and internationally because they may contain potentially out-of-specification endotoxin levels and lack sterility assurance.
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. Per the severity rubric, FDA Class I recalls that do not involve known fatalities are classified as Severe (score 4).
Plain-English summary
Integra LifeSciences Corp. (NeuroSciences) is recalling Extended Tip Applicator 8CM, Box of 1 (Model/Catalog Number 201108; UDI 10381780000167; all lots). The devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.
The recalled devices were distributed domestically across 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, and Panama. They were also distributed from Belgium to Austria, Belgium, Cyprus, Czechia, France, Georgia, Germany, Greece, Hungary, Iran, Ireland, Italy, Jordan, Malta, Netherlands, Nigeria, Palestine, Portugal, Romania, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and Turkey.
Patients and healthcare providers who have these devices should stop using them and contact Integra LifeSciences for instructions on return and replacement. Healthcare facilities should review their inventory and quarantine affected units immediately.
The recalled product
- Product
- Extended Tip Applicator 8CM, Box of 1.
- Manufacturer
- Integra LifeSciences Corp. (NeuroSciences)
- 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: 201108
- UDI 10381780000167
- All Lots.
Distribution
Distributed nationwide across the United States.
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