Class 2 Device Recall Hulka Clip

• Date Initiated by Firm: October 16, 2009
• Date Posted: November 17, 2009
• Recall Status: Terminated on March 16, 2011
• Recall Number: Z-0272-2010
• Recall Event ID: 53586
• PMA Number: P870080
• Product Classification: tubal occlusion device - Product Code HGB
• Product: Richard Wolf Hulka Clip; for single patient use only; a sterile tubal occluding device; 2 clips per procedure tray/pouch, 10 pouches per shipping carton; Richard Wolf Medical Instruments Corp., Vernon Hills, IL 60061; item 4986.90. Indicated for use for female sterilization (permanent contraception) by occluding the fallopian tubes
• Code Information: lot number 1391, expiry date 02.2010
• Recalling Firm/ Manufacturer: Richard Wolf Medical Instruments Corp.; 353 Corporate Woods Pkwy; Vernon Hills IL 60061-3110
• For Additional Information Contact: Customer Service; 800-323-9653
• Manufacturer Reason for Recall: The sterile pouch seal may fail to remain intact during handling rendering the Hulka clip non-sterile.
• FDA Determined Cause: Packaging
• Action: Richard Wolfe sent recall letters dated October 16, 2009 to the direct accounts via certified mail on the same date. The accounts were informed that the lot of Hulka clips did not meet their sterile seal burst test requirements, and that the sterile seal may fail to remain intact during handling, resulting in the clips becoming contaminated or non-sterile. They were instructed to inspect their inventory for the affected lot, quarantine any product found and call Richard Wolf at 800-323-9653, ext 225 or 380 to arrange for the return of the affected product for replacement. The accounts were also requested to complete and return the enclosed response form to Richard Wolf, even if they do not have any of the affected lot in stock.
• Quantity in Commerce: 150 cartons
• Distribution: Nationwide
• 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.