FDA Medical Device Recalls (openFDA)
ConvaTec: Unilect ECG Electrodes Unomedical, McAllen Texas. Intended use:Cardiac monitoring
- Recall number
- Z-1431-2010
- Recalling firm
- ConvaTec
- Product
- Unilect ECG Electrodes Unomedical, McAllen Texas. Intended use:Cardiac monitoring
- Status
- Terminated
- Initiated
- 2010-03-11
- Posted
- 2010-04-22
- Terminated
- 2011-06-21
- Reason
- 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.
- Root cause
- Process design
- Action
- 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.
- Quantity
- 567,000 units
- Distribution
- Nationwide distribution: CA
- Lot, serial or model codes
- Model Number 4560M; Lots: 706268, 708152, 709705, 711967, 713648, 713977, 714391, 714392, 714685, 714687.
- 510(k) numbers
- ["K990113"]
- PMA numbers
- not on file
- Product code
- DRX
- Firm FEI
- 3011987967
- Firm city
- Skillman
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28