Integra Selector Kit Sterile single use device A recall
Integra Selector Kit Sterile single use device A bi-lumen, sterile single use accessory used for the Selector Integra Ultrasonic Surgical Aspirator…
Why was Integra Selector Kit Sterile single use device A recalled?
Some specific lots of Selector Tubing may potentially leak irrigation fluid during use if not placed on the Selector handpiece in a specific manner.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Numbers: 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;1134671;1134694;1134695;1140357;1141561;1141562;1141645;1141754;1141563;1141564;1141647;1142352;1142353;1142409; & 1142410
- Product
- Integra Selector Kit Sterile single use device A bi-lumen, sterile single use accessory used for the Selector Integra Ultrasonic Surgical Aspirator…
- Recalling firm
- Integra LifeSciences Corp.
- Quantity
- 6,358 tubing kits
- Distribution
- Worldwide Distribution - USA (nationwide) and Internationally to Algeria, Australia, Bulgaria, Canada, Germany, Great Britain, Greece, Hungary, Indonesia, Israel, Italy, Japan, Mexico, Portugal, Spain, Sweden, Thailand, Turkey, and Wales.
- Recall date
- December 10, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)