Class 2 Device Recall Vascular Drape

• Date Initiated by Firm: December 20, 2007
• Date Posted: July 23, 2008
• Recall Status: Terminated on July 22, 2008
• Recall Number: Z-1372-2008
• Recall Event ID: 46212
• Product Classification: Surgical drape and drape accessories - Product Code KKX
• Product: Vascular Drape, Surgical drape and drape accessories; Reference Number: EF 00-902776-01; Packaged in a box of 10.
• Code Information: Lot Number: 172010207.
• Recalling Firm/ Manufacturer: OEC Medical Systems, Inc; 384 Wright Brothers Dr; Salt Lake City UT 84116-2862
• For Additional Information Contact: 801-517-6440
• Manufacturer Reason for Recall: No Premarket Notification: Product does not have FDA 510(k) approval for use.
• FDA Determined Cause: PMA
• Action: Consignees were notified by an Urgent Recall Notice letter on 12/20/2007. The letter instructed users to stop using and to dispose of the recalled drapes. For additional information, contact 1-800-874-7378.
• Quantity in Commerce: 158 units
• Distribution: Nationwide Distribution including states of AL, CA, FL, MA, MD, MO, NJ, NY, PA, OR, SC and TX.
• 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.