Integra Selector Kit Tubing Recalled for Potential Irrigation Fluid Leakage
Integra LifeSciences is recalling 6,358 Selector Kit tubing units because they may leak irrigation fluid during use if not placed correctly on the handpiece.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (fluid leakage) in a medical device where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Integra LifeSciences Corp. is recalling 6,358 units of the Selector Kit, a sterile single-use bi-lumen tubing accessory used with the Selector Integra Ultrasonic Surgical Aspirator system. The recall is due to a potential defect where the tubing may leak irrigation fluid during use if it is not placed on the Selector handpiece in a specific manner.
The affected products were distributed worldwide, including nationwide in the United States and internationally to countries such as Algeria, Australia, Bulgaria, Canada, Germany, Great Britain, Greece, Hungary, Indonesia, Israel, Italy, Japan, Mexico, Portugal, Spain, Sweden, Thailand, Turkey, and Wales. The recall covers specific lot numbers, including 130849, 1132912, 1132913, 1132914, 1133101, 1133102, 1133103, 1133104, 1133105, 1133495, 1134005, 1134006, 1134007, 1134120, 1134121, 1134122, 1134124, 1134126, 1134128, 1134130, 1134131, 1134132, 1134133, 1134620, 1134621, 1134669, 1134670, 1134671, 1134694, 1134695, 1140357, 1141561, 1141562, 1141645, 1141754, 1141563, 1141564, 1141647, 1142352, 1142353, 1142409, and 1142410.
Healthcare providers and facilities using the Selector Integra Ultrasonic Surgical Aspirator system should check their inventory for the affected lot numbers and stop using the recalled tubing kits. The device is intended for use by surgeons in neurosurgery and gastroenterology, including laparoscopic procedures.
The recalled product
- Product
- Integra Selector Kit Sterile single use device A bi-lumen, sterile single use accessory used for the Selector Integra Ultrasonic Surgical Aspirator system. One of the tubing lumen transmits irrigation fluid from the console to the handpiece of the system, and the other tubing lu
- Manufacturer
- Integra LifeSciences Corp.
- Hazard
- Affected units
- 6,358
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 (20)
- Lot Numbers: 130849
- 1132912
- 1132913
- 1132914
- 1133101
- 1133102
- 1133103
- 1133104
- 1133105
- 1133495
- 1134005
- 1134006
- 1134007
- 1134120
- 1134121
- 1134122
- 1134124
- 1134126
- 1134128
- 1134130
Distribution
Distributed nationwide across the United States.
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