Unilect ECG Electrodes Unomedical, McAllen Texas. Intended use:Cardiac monitoring
This recall has been terminated (originally issued April 22, 2010).
- Company
- Convatec
- Recall Initiated
- March 11, 2010
- Posted
- April 22, 2010
- Terminated
- June 21, 2011
- Recall Number
- Z-1431-2010
- Quantity
- 567,000 units
- Firm Location
- Skillman, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
In an emergency situation where defibrillation is necessary and electrodes are already in use, the electrodes may malfunction and incorrectly report lack of cardiac activity.
Distribution
Nationwide distribution: CA
Lot / Code Info
Model Number 4560M; Lots: 706268, 708152, 709705, 711967, 713648, 713977, 714391, 714392, 714685, 714687.
Root Cause
Process design
Action Taken
The one distributor was notified personally on March 9, 2010. All remaining stock was put on hold, and a "URGENT : MEDICAL DEVICE RECALL" letter dated March 11, 2010, was sent to customers. The letter describes the product, problem and action to be taken by customers. All customers were asked to immediately stop distributing and quarantine all recalled lots. The customers were ask to perform a count of recalled product currently in inventory, complete and return the Recall Response Form even if no recalled product is in inventory, send a copy of response to distributor in order to receive reimbursement, and to call 1-800-582-6514 for instructions on how to return the recalled product. If you have any questions, please contact Convatec at 908-904-2425.