FDA Medical Device Recalls (openFDA)
Integra Life Sciences Corporation: Single Shot Epidural Tray, Disposable, Convenience Kit, Reorder Number SS1719, Integra LifeSciences Corporation, Salt Lake City, Utah 84104. Kits contain syringes, drugs, sponges, drapes and other products supplied by outside manufacturers / vendors to aid in certain medical / surgical procedures.
- Recall number
- Z-2106-2009
- Recalling firm
- Integra Life Sciences Corporation
- Product
- Single Shot Epidural Tray, Disposable, Convenience Kit, Reorder Number SS1719, Integra LifeSciences Corporation, Salt Lake City, Utah 84104. Kits contain syringes, drugs, sponges, drapes and other products supplied by outside manufacturers / vendors to aid in certain medical / surgical procedures.
- Status
- Terminated
- Initiated
- 2009-07-13
- Posted
- 2009-09-21
- Terminated
- 2009-10-23
- Reason
- Lack of packaging seal integrity on various pain management kits may compromise sterility of contents.
- Root cause
- Packaging process control
- Action
- 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.
- Quantity
- 10 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.
- Lot, serial or model codes
- Lot number W0906019
- 510(k) numbers
- ["K945484","K960248"]
- PMA numbers
- not on file
- Product code
- CAZ
- Firm FEI
- 1000138491
- Firm city
- Salt Lake City
- Firm state
- UT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28