Recall Z-1154-06 ยท KKX Drape, Surgical, Antimicrobial
Abbott Spine
Stericover/ Sterile Disposible Polyethylene Drape ---Universal Video Camera/ Laser Arm Equipment Cover; 7'' x 96''.
| Date | Jun 17, 2006 (initiated May 15, 2006) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.