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
FDA Recall Z-0802-03 · Posted 2003-05-09
Recalling FirmHu-Friedy Mfg Co, Inc.
Recall StatusTerminated
Product CodeGAB
Date Initiated2003-04-10
Date Terminated2004-03-24
Product Quantity200 vials
Reason for Recall
The suture needles were mislabeled with the wrong size.
Firm 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.
Root Cause
Other
Distribution Pattern
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.