FDA Medical Device Recalls (openFDA)
Abbott Spine: Stericover/ Sterile Disposible Polyethylene Drape ---Universal Video Camera/ Laser Arm Equipment Cover; 7'' x 96''.
- Recall number
- Z-1154-06
- Recalling firm
- Abbott Spine
- Product
- Stericover/ Sterile Disposible Polyethylene Drape ---Universal Video Camera/ Laser Arm Equipment Cover; 7'' x 96''.
- Status
- Terminated
- Initiated
- 2006-05-15
- Posted
- 2006-06-17
- Terminated
- 2007-09-25
- Reason
- Non-sterility-Distributor testing of outside manufacturer's product (Sterimed, Inc) revealed positive sterility test results.
- Root cause
- Other
- Action
- Firm notified sales agents of recall via telephone on 05/15/06 and requested product returns for destruction
- Quantity
- 326 units.
- Distribution
- NATIONWIDE-Drapes consigned to sales agents located in CA, FL, IL, MD, MI, OK, OH, TX, and WI.
- Lot, serial or model codes
- Lot #s: 0796316, 0796319 and 0796320.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KKX
- Firm FEI
- 3000718496
- Firm city
- Austin
- Firm state
- TX
- 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