Recall Z-0802-03 ยท GAB Needle, Suturing, Disposable
Hu-Friedy Mfg Co, Inc.
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
| Date | May 9, 2003 (initiated Apr 10, 2003) |
| Status | Terminated |
| Reason | The suture needles were mislabeled with the wrong size. |
| Root 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.