Recall Z-1372-2008 ยท KKX Drape, Surgical, Antimicrobial
OEC Medical Systems, Inc
Vascular Drape, Surgical drape and drape accessories; Reference Number: EF 00-902776-01; Packaged in a box of 10.
| Date | Jul 23, 2008 (initiated Dec 20, 2007) |
| Status | Terminated |
| Reason | No Premarket Notification: Product does not have FDA 510(k) approval for use. |
| Root cause | PMA |
| Action | Consignees were notified by an Urgent Recall Notice letter on 12/20/2007. The letter instructed users to stop using and to dispose of the recalled drapes. For additional information, contact 1-800-874-7378. |
| Quantity | 158 units |
| Distribution | Nationwide Distribution including states of AL, CA, FL, MA, MD, MO, NJ, NY, PA, OR, SC and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.