R2 Adult Zoll Non-Radiolucent Multifunction Electrodes, Catalog/REF 3111-1721, NON-STERILE, ASSEMBLED IN MEXICO, CONMED
FDA device recall Z-0735-2012 · posted 2012-01-12 · Terminated
Recall details
- Recalling firm
- ConMed Corporation
- Reason for recall
- The product lot was assembled with an R2 Connector, rather than a Zoll Connector.
- Action taken
- ConMed Corporation sent an "URGENT: DEVICE RECALL" letter dated March 9, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to review their inventory for the affected product and to stop use of the devices immediately. A Business Reply Form was attached for customers to complete and return to the firm via fax to 315-624-3225. Additionally, instructions were provided on how to return the affected devices. Contact the ConMed Recall Coordinator at 315-624-3237 for questions regarding this notice.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- LDD
- Quantity affected
- 190 sets (2 pads per set in individual pouch)
- Distribution
- Nationwide Distribution-including the states of AZ, CA, IN, and MI.
- Date initiated
- 2011-03-09
- Date posted
- 2012-01-12
- Date terminated
- 2012-01-12
- Location
- Utica, NY
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| 700-F SERIES STIMULATION ELECTRODES (K964469) | Cardiotronics Systems, Inc. | 1996-12-11 |