Recall Z-1610-2010 ยท GAG Stapler, Surgical
Cardinal Health
Disposable Skin Stapler - 35 Wide; Surgical Skin Stapler; Rx, sterile, single use skin stapler, individually packaged in a thermo-formed tray with a Tyvek lid, 5 trays per box; Distributed by Cardinal Health, Dublin, OH 43017, Made in China; catalog number FS-35W. Designed to close incisions during a surgical procedure.
| Date | May 19, 2010 (initiated Apr 1, 2010) |
| Status | Terminated |
| Reason | The sterility of the staplers is questionable. |
| Root cause | Packaging process control |
| Action | Cardinal Health issued an "Urgent: Product Recall" letter dated April 1, 2010 to all customers who may have received affected product. Customers were instructed to immediately quarantine any affected inventory, return the notification acknowledgement form and return the product to the firm. For further information, contact Cardinal Health Customer Service at 1-888-444-5440. |
| Quantity | 1,638 units |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.