Universal Block Tray, Disposable, Convenience Tray, Reorder Number CUS1407-06, Integra LifeSciencesCorporation, Salt Lak
FDA device recall Z-2080-2009 · posted 2009-09-21 · Terminated
Recall details
- Recalling firm
- Integra Life Sciences Corporation
- Reason for recall
- Lack of packaging seal integrity on various pain management kits may compromise sterility of contents.
- Action taken
- Consignees were notified by telephone on July 09, 2009 and by "Urgent Medical Device Recall" letter on July 13, 2009. Customers were instructed to immediately examine inventory, cease use and distribution of any affected product and to contact Integra Pain Management Customer Service by calling 1-800-241-2210 to arrange for return and replacement. Refer questions to Integra Pain Management by calling 1-800-241-2210.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- CAZ
- Quantity affected
- 600 units
- Distribution
- Worldwide Distribution -- US (states of AK, AR, AZ, CA, CO, CT, FL, GA, HI, ID, IN, KY, ME, MO, NC, NJ, NV, NY, OH, OK, PA, RI, SD, ST, TX and UT), Belgium and Japan.
- Date initiated
- 2009-07-13
- Date posted
- 2009-09-21
- Date terminated
- 2009-10-23
- Location
- Salt Lake City, UT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GENERAL PROCEDURE KIT (K960248) | Physician Industries, Inc. | 1996-04-12 |
| PIDURAL STEROID SYSTEM (K945484) | Professional Medical Device Consultants | 1995-06-02 |