Z-1154-06

Stericover/ Sterile Disposible Polyethylene Drape ---Universal Video Camera/ Laser Arm Equipment Cover; 7'' x...

Name: Z-1154-06 Stericover/ Sterile Disposible Polyethylene Drape ---Universal Video Camera/ Laser Arm Equipment Cover; 7'' x...
Creator: Abbott Spine
Published: 2006-05-15
License: https://open.fda.gov/license/

Spinal Concepts, Inc. / initiated 2006-05-15 / Terminated / root cause: sterility

FDA source

Abbott Spine began a recall of Stericover/ Sterile Disposible Polyethylene Drape ---Universal Video Camera/ Laser Arm Equipment Cover; 7'' x 96'' on 2006-05-15. The reason FDA records is "Non-sterility-Distributor testing of outside manufacturer's product (Sterimed, Inc) revealed positive sterility test results". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-1154-06
Status: Terminated
Initiated: 2006-05-15
Posted: 2006-06-17
Terminated: 2007-09-25
Recalling firm: Spinal Concepts, Inc.
Product: Stericover/ Sterile Disposible Polyethylene Drape ---Universal Video Camera/ Laser Arm Equipment Cover; 7'' x 96''.
Product code: KKX Drape, Surgical, Antimicrobial
Reason for recall: Non-sterility-Distributor testing of outside manufacturer's product (Sterimed, Inc) revealed positive sterility test results.
Root cause tag: sterility
FDA root cause: Other
Action: Firm notified sales agents of recall via telephone on 05/15/06 and requested product returns for destruction
Quantity in commerce: 326 units.
Distribution: NATIONWIDE-Drapes consigned to sales agents located in CA, FL, IL, MD, MI, OK, OH, TX, and WI.
Product codes and lots: Lot #s: 0796316, 0796319 and 0796320.

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)