Recall Z-0613-2007 ยท KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Gyrus ACMI Corporation
Gyrus ACMI Tripolar Ultra Cutting Forceps: 5 mm X 32 cm-Reference Number: TRU5-32
| Date | Mar 13, 2007 (initiated Feb 19, 2007) |
| Status | Terminated |
| Reason | Product sterility may be compromised due to failure of the tray seal packaging |
| Root cause | Packaging process control |
| Action | Gyrus ACMi issued recall letters on 2/19/07. Each account is asked to remove recalled product and return product . |
| Quantity | 527 boxes (5 units/box) |
| Distribution | Worldwide distribution ----USA and countries of Canada, The Netherlands, Japan, Portugal, Columbia, South Africa, Australia, and Spain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K932293 | CABOT MEDICAL BIPOLAR CUTTING FORCEPS Cabot Medical Corp., Jul 27, 1994 |