Vascular Drape, Surgical drape and drape accessories; Reference Number: EF 00-902776-01; Packaged in a box of 10.
This recall has been terminated (originally issued July 23, 2008).
- Company
- Oec Medical Systems, Inc
- Recall Initiated
- December 20, 2007
- Posted
- July 23, 2008
- Terminated
- July 22, 2008
- Recall Number
- Z-1372-2008
- Quantity
- 158 units
- Firm Location
- Salt Lake City, UT
- Official Source
- View on FDA website ↗
Reason for Recall
No Premarket Notification: Product does not have FDA 510(k) approval for use.
Distribution
Nationwide Distribution including states of AL, CA, FL, MA, MD, MO, NJ, NY, PA, OR, SC and TX.
Lot / Code Info
Lot Number: 172010207.
Root Cause
PMA
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.
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