FDA Device

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

Hazard

Non-sterility-Distributor testing of outside manufacturer's product (Sterimed, Inc) revealed positive sterility test results.

What You Should Do

Remedy

Firm notified sales agents of recall via telephone on 05/15/06 and requested product returns for destruction

Products

Stericover/ Sterile Disposible Polyethylene Drape ---Universal Video Camera/ Laser Arm Equipment Cover; 7'' x 96''.
Brand
Abbott Spine
UPC
Lot #s: 0796316, 0796319 and 0796320.

Units Affected

326 units.