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
This recall has been terminated (originally issued May 9, 2003).
- Company
- Hu-Friedy Mfg Co, Inc.
- Recall Initiated
- April 10, 2003
- Posted
- May 9, 2003
- Terminated
- March 24, 2004
- Recall Number
- Z-0802-03
- Quantity
- 200 vials
- Firm Location
- Chicago, IL
- Official Source
- View on FDA website ↗
Reason for Recall
The suture needles were mislabeled with the wrong size.
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.
Lot / Code Info
Partcode SN4, all units distributed between 1/3/01 and 3/10/03.
Root Cause
Other
Action Taken
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.