Gyrus ACMI Tripolar Ultra Cutting Forceps: 10 mm X 32 cm w/rotation-Reference Number: 006689-903
FDA device recall Z-0615-2007 · posted 2007-03-13 · Terminated
Recall details
- Recalling firm
- Gyrus ACMI Corporation
- Reason for recall
- Product sterility may be compromised due to failure of the tray seal packaging
- Action taken
- Gyrus ACMi issued recall letters on 2/19/07. Each account is asked to remove recalled product and return product .
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- KNS
- Quantity affected
- 11 boxes (5 units/box)
- Distribution
- Worldwide distribution ----USA and countries of Canada, The Netherlands, Japan, Portugal, Columbia, South Africa, Australia, and Spain.
- Date initiated
- 2007-02-19
- Date posted
- 2007-03-13
- Date terminated
- 2008-02-24
- Location
- Southborough, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CABOT MEDICAL BIPOLAR CUTTING FORCEPS (K932293) | Cabot Medical Corp. | 1994-07-27 |