Vascular Drape, Surgical drape and drape accessories; Reference Number: EF 00-902776-01; Packaged in a box of 10.
FDA device recall Z-1372-2008 · posted 2008-07-23 · Terminated
Recall details
- Recalling firm
- OEC Medical Systems, Inc
- Reason for recall
- No Premarket Notification: Product does not have FDA 510(k) approval for use.
- Action taken
- 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.
- Root cause
- PMA
- Status
- Terminated
- Product code
- KKX
- Quantity affected
- 158 units
- Distribution
- Nationwide Distribution including states of AL, CA, FL, MA, MD, MO, NJ, NY, PA, OR, SC and TX.
- Date initiated
- 2007-12-20
- Date posted
- 2008-07-23
- Date terminated
- 2008-07-22
- Location
- Salt Lake City, UT
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