ADP2.1 Adapter, non-sterile reusable Model Number: 30-802-1 ,an accessory used with the TissueLink BiPolar Floating Devi
FDA device recall Z-1415-04 · posted 2004-09-01 · Terminated
Recall details
- Recalling firm
- TissueLink Medical, Inc.
- Reason for recall
- Adapter when connected to a generator may short circuit resulting in lack of power and/or thermal warming of the ADP housing.
- Action taken
- TissueLink notified the sales force on 7/22/04 to visit each account and retreive product at the hospital level.
- Root cause
- Other
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 164 units
- Distribution
- Nationwide
- Date initiated
- 2004-07-22
- Date posted
- 2004-09-01
- Date terminated
- 2004-10-04
- Location
- Dover, NH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TISSUELINK BIPOLAR FLOATING BALL DEVICE (K022532) | Tissuelink Medical, Inc. | 2003-02-12 |
| TISSUELINK BIPOLAR FLOATING BALL DEVICE (K020574) | Tissuelink Medical, Inc. | 2002-05-20 |