ClearanceBrief
Recall Z-1154-06 ยท KKX Drape, Surgical, Antimicrobial

Abbott Spine

Stericover/ Sterile Disposible Polyethylene Drape ---Universal Video Camera/ Laser Arm Equipment Cover; 7'' x 96''.

DateJun 17, 2006 (initiated May 15, 2006)
StatusTerminated
ReasonNon-sterility-Distributor testing of outside manufacturer's product (Sterimed, Inc) revealed positive sterility test results.
Root causeOther
ActionFirm notified sales agents of recall via telephone on 05/15/06 and requested product returns for destruction
Quantity326 units.
DistributionNATIONWIDE-Drapes consigned to sales agents located in CA, FL, IL, MD, MI, OK, OH, TX, and WI.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.