Recall Z-0613-2007
Gyrus ACMI Corporation · initiated February 19, 2007
Product
Gyrus ACMI Tripolar Ultra Cutting Forceps: 5 mm X 32 cm-Reference Number: TRU5-32
Codes / lots: Lot Nos. : 6236019, 6236020, 6236021, 6258015, 6297001, 6300013, 6306015, 6320041, 6326021, 6326097, 6335042, 6342008, 6349001, 6349002, 6355029, 7011002, 7011003, 7019012
Reason for recall
Product sterility may be compromised due to failure of the tray seal packaging
FDA-determined cause: Packaging process control
Action taken
Gyrus ACMi issued recall letters on 2/19/07. Each account is asked to remove recalled product and return product .
Details
- Recall number
- Z-0613-2007
- Initiated
- February 19, 2007
- Posted by FDA
- March 13, 2007
- Terminated
- February 24, 2008
- Product code
- KNS – Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
- Quantity
- 527 boxes (5 units/box)
- Distribution
- Worldwide distribution ----USA and countries of Canada, The Netherlands, Japan, Portugal, Columbia, South Africa, Australia, and Spain.
- Recalling firm
- Gyrus ACMI Corporation, Southborough, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0614-2007 | Gyrus ACMI Tripolar Ultra Cutting Forceps: 10 mm X 32 cm-Reference Number: 006689-901Product sterility may be compromised due to failure of the tray seal packaging | 02/19/2007Terminated |
| Z-0615-2007 | Gyrus ACMI Tripolar Ultra Cutting Forceps: 10 mm X 32 cm w/rotation-Reference Number:…Product sterility may be compromised due to failure of the tray seal packaging | 02/19/2007Terminated |