Integra Selector Kit Sterile single use device A bi-lumen, sterile single use accessory used for the Selector Integra Ul
FDA device recall Z-0491-2015 · posted 2014-12-01 · Terminated
Recall details
- Recalling firm
- Integra LifeSciences Corp.
- Reason for recall
- Some specific lots of Selector Tubing may potentially leak irrigation fluid during use if not placed on the Selector handpiece in a specific manner.
- Action taken
- Integra sent an 'Urgent- Medical Device Correction' letters/acknowledgement forms dated 9/29/2014 by traceable courier service. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review their inventory for the affected product, complete the attached form. Complete the other information on the form and return the form by email or fax. Customers with questions should contact Customer Service at 1-855-532-1723.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- LFL
- Quantity affected
- 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
- Date initiated
- 2014-09-29
- Date posted
- 2014-12-01
- Date terminated
- 2015-05-27
- Location
- Plainsboro, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CUSA SELECTOR NXT ULTRASONIC TISSUE ABLATION SYSTEM (K081459) | Integra Radionics, Inc. | 2008-08-13 |