FDA Medical Device Recalls (openFDA)
OEC Medical Systems, Inc: Vascular Drape, Surgical drape and drape accessories; Reference Number: EF 00-902776-01; Packaged in a box of 10.
- Recall number
- Z-1372-2008
- Recalling firm
- OEC Medical Systems, Inc
- Product
- Vascular Drape, Surgical drape and drape accessories; Reference Number: EF 00-902776-01; Packaged in a box of 10.
- Status
- Terminated
- Initiated
- 2007-12-20
- Posted
- 2008-07-23
- Terminated
- 2008-07-22
- 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.
- Lot, serial or model codes
- Lot Number: 172010207.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KKX
- Firm FEI
- 1720753
- Firm city
- Salt Lake City
- Firm state
- UT
- 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