Non-Sterile Suture Needles, Reverse Cutting, 1/2 Circle, Stainless Steel; 12 suture needles per glass vial; partcode: SN
FDA device recall Z-0802-03 · posted 2003-05-09 · Terminated
Recall details
- Recalling firm
- Hu-Friedy Mfg Co, Inc.
- Reason for recall
- The suture needles were mislabeled with the wrong size.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- GAB
- Quantity affected
- 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, Aust
- Date initiated
- 2003-04-10
- Date posted
- 2003-05-09
- Date terminated
- 2004-03-24
- Location
- Chicago, IL
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