Extended Tip Applicator 15 CM recalled for endotoxin and sterility issues
Integra LifeSciences is recalling Extended Tip Applicators (15 CM, Box of 5) because they may contain out-of-specification levels of endotoxins and lack sterility assurance.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall of a medical device. Per the rubric, FDA Class I recalls with potential for serious health consequences receive a severity score of 4 (Severe).
Plain-English summary
Integra LifeSciences Corp. (NeuroSciences) is recalling the Extended Tip Applicator, 15 CM, Box of 5 (Model/Catalog Number 205115, UDI 10381780000150, all lots). The devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.
The affected devices were distributed nationwide in 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. Additionally, devices were distributed from Belgium to Austria, 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. A total of 2,524 units were affected.
Endotoxin contamination and loss of sterility assurance in medical devices can pose serious health risks. Customers who have received these applicators should stop using them and contact Integra LifeSciences Corp. for further instructions regarding replacement or return of the recalled devices.
The recalled product
- Product
- Extended Tip Applicator, 15 CM, Box of 5.
- Manufacturer
- Integra LifeSciences Corp. (NeuroSciences)
- Affected units
- 2,524
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.
Part of a larger recall action
This product is one of 3 recalled by Integra LifeSciences Corp. (NeuroSciences) under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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