Megadyne MegaTip, Modified E-Z Clean Non Stick Cautery Tip, CAT/REF 0600M, Single Use Only, STERILE
FDA device recall Z-0469-03 · posted 2003-01-30 · Terminated
Recall details
- Recalling firm
- Megadyne Medical Products, Inc
- Reason for recall
- The metal substrate cautery tip may break during use.
- Action taken
- On 12/20/2002, all consignees were notified by letter to return all affected product.
- Root cause
- Other
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 4855
- Distribution
- Nationwide. Foreign distribution to Australia, Belgium, Canada, Italy, Korea, New Zealand, Sweden.
- Date initiated
- 2002-12-20
- Date posted
- 2003-01-30
- Date terminated
- 2003-09-05
- Location
- Draper, UT
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ELECTROSURGICAL CUTTING AND COAGULATING DEVICE AND ACCESSORIES (K943055) | Megadyne Medical Products, Inc. | 1994-12-21 |