Aquamantys 2.3 Bipolar Sealer Model #23-113-1. Product Usage: The Aquamantys Bipolar Sealer is a sterile, bipolar electr
FDA device recall Z-2892-2011 · posted 2011-07-28 · Terminated
Recall details
- Recalling firm
- Salient Surgical Technologies, Inc
- Reason for recall
- Insulating material on the shaft of the device may separate and expose the electrical conductor and result in burning the patient skin
- Action taken
- Salient Surgical Technologies, Inc. sent an "URGENT MEDICAL DEVICE RECALL" notification letter dated July 18, 2011 to all affected customers and distributors. The letter describes the product, problem and the actions to be taken. The letter requested that customers and distributors immediately identify and discontinue use of all Aquamantys 2.3 Bipolar Sealer devices in inventory and quarantine them until they can be returned to Salient. The letter states that a Salient sales representative will arrange return of the recalled product to Salient. The letter provides information for customers about the replacement of the recalled product. If you have any questions, please contact Customer Service, at 866-777-9400, or your sales representative.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Quantity affected
- 48, 963 units
- Distribution
- Worldwide Distribution - USA (nationwide) and countries of China, Denmark, France, Germany, Greece, Italy, Japan, , South Africa, Spain, and Turkey.
- Date initiated
- 2011-07-18
- Date posted
- 2011-07-28
- Date terminated
- 2012-03-09
- Location
- Portsmouth, NH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AQUAMANTYS PUMP GENERATOR SYSTEM (K052859) | Tissuelink Medical, Inc. | 2005-10-25 |