R2 Adult R2 Non-Radiolucent Multifunction Electrodes, Catalog/REF No. 3200-1715, NON-STERILE, MADE IN USA, CONMED CORPOR
FDA device recall Z-0856-2012 · posted 2012-01-25 · Terminated
Recall details
- Recalling firm
- ConMed Corporation
- Reason for recall
- The specific lot was assembled without the rivet cover.
- Action taken
- ConMed Corporation sent a Urgent Medical Device Recall Letter dated March 25, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to immediately stop use of the device and return it to ConMed Corporation. Please review your inventory for any of the devices listed on Attachment I. If you do not have any devices to return, please follow the instructions in the letter and complete Attachment II, indicating you have no devices and fax it to 315-624-3225. Please complete the attached Business reply form. We apologize for any inconvenience this will cause you or your staff. For further questions please call (315) 797-8375.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- MLN
- Quantity affected
- 850 sets (2 pads per set in individual pouch)
- Distribution
- Worldwide Distribution -- USA (nationwide) and the countries of Canada, Belgium, Germany and Hong Kong.
- Date initiated
- 2011-03-31
- Date posted
- 2012-01-25
- Date terminated
- 2012-01-26
- Location
- Utica, NY
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| 700-F SERIES STIMULATION ELECTRODES (K964469) | Cardiotronics Systems, Inc. | 1996-12-11 |