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U.S. Department of Health and Human Services

Class 2 Device Recall Stericover

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  Class 2 Device Recall Stericover see related information
Date Initiated by Firm May 15, 2006
Date Posted June 17, 2006
Recall Status1 Terminated 3 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.
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 2		 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.
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