Z-1372-2008

Vascular Drape, Surgical drape and drape accessories; Reference Number: EF 00-902776-01; Packaged in a box of...

Name: Z-1372-2008 Vascular Drape, Surgical drape and drape accessories; Reference Number: EF 00-902776-01; Packaged in a box of...
Creator: OEC Medical Systems, Inc
Published: 2007-12-20
License: https://open.fda.gov/license/

GE Healthcare / initiated 2007-12-20 / Terminated

FDA source

OEC Medical Systems, Inc began a recall of Vascular Drape, Surgical drape and drape accessories; Reference Number: EF 00-902776-01; Packaged in a box of 10 on 2007-12-20. The reason FDA records is "No Premarket Notification: Product does not have FDA 510(k) approval for use". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1372-2008
Status: Terminated
Initiated: 2007-12-20
Posted: 2008-07-23
Terminated: 2008-07-22
Recalling firm: GE Healthcare
Product: Vascular Drape, Surgical drape and drape accessories; Reference Number: EF 00-902776-01; Packaged in a box of 10.
Product code: KKX Drape, Surgical, Antimicrobial
Reason for recall: No Premarket Notification: Product does not have FDA 510(k) approval for use.
FDA 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 in commerce: 158 units
Distribution: Nationwide Distribution including states of AL, CA, FL, MA, MD, MO, NJ, NY, PA, OR, SC and TX.
Product codes and lots: Lot Number: 172010207.

Product code KKX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)