Class 2 Device Recall HuFriedy

• Date Initiated by Firm: April 10, 2003
• Date Posted: May 09, 2003
• Recall Status: Terminated on March 24, 2004
• Recall Number: Z-0802-03
• Recall Event ID: 25958
• Product Classification: unknown device name - Product Code GAB--
• Product: Non-Sterile Suture Needles, Reverse Cutting, 1/2 Circle, Stainless Steel; 12 suture needles per glass vial; partcode: SN4; Hu-Friedy Mfg. Co., Inc., 3232 N. Rockwell St., Chicago, IL 60618
• Code Information: Partcode SN4, all units distributed between 1/3/01 and 3/10/03.
• Recalling Firm/ Manufacturer: Hu-Friedy Mfg Co, Inc.; 3232 N Rockwell; Chicago IL 60618-5935
• For Additional Information Contact: Mr. Keith R. Dunn; 773-975-6100
• Manufacturer Reason for Recall: The suture needles were mislabeled with the wrong size.
• FDA Determined Cause: Other
• Action: Hu-Friedy sent recall letters dated 4/10/03 to their accounts on the same date, informing them that the incorrect size needle was packaged as SN4 suture needles, and requesting them to quarantine all warehouse stocks of SN4 suture needles for return to Hu-Friedy for replacement and to notify their sub-accounts.
• Quantity in Commerce: 200 vials
• Distribution: Michigan, Massachusetts, California, Pennsylvania, Texas, Washington, New York, Wisconsin, Iowa, Indiana, Tennessee, New Jersey, Louisiana, South Carolina, Florida, and internationally to Canada, Australia and New Zealand.

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.