Class 2 Device Recall Stericover

• Date Initiated by Firm: May 15, 2006
• Date Posted: June 17, 2006
• Recall Status: Terminated on September 25, 2007
• Recall Number: Z-1154-06
• Recall Event ID: 35508
• Product Classification: Drape, polyethylene - Product Code KKX
• Product: Stericover/ Sterile Disposible Polyethylene Drape ---Universal Video Camera/ Laser Arm Equipment Cover; 7'' x 96''.
• Code Information: Lot #s: 0796316, 0796319 and 0796320.
• FEI Number: 3000718496
• Recalling Firm/ Manufacturer: Abbott Spine; 12708 Riata Vista Cir # B-100; Austin TX 78727-7167
• Manufacturer Reason for Recall: Non-sterility-Distributor testing of outside manufacturer's product (Sterimed, Inc) revealed positive sterility test results.
• FDA Determined 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.