FDA Medical Device Recalls (openFDA)
ConvaTec: Neutralect Diathermy Cable, Unomedical Ltd., Ref code 3508M, and Ref Code 3405M.
- Recall number
- Z-1142-2010
- Recalling firm
- ConvaTec
- Product
- Neutralect Diathermy Cable, Unomedical Ltd., Ref code 3508M, and Ref Code 3405M.
- Status
- Terminated
- Initiated
- 2010-01-22
- Posted
- 2010-03-16
- Terminated
- 2010-06-10
- Reason
- Mislabeling: Boxes labeled with the order code 3508M may contain a cable for the order code 3405M, and boxes labeled with order code 3405M may contain a cable for order code 3508M.
- Root cause
- Other
- Action
- Unomedical Urgent Medical Device Correction letters were sent to distributors on January 22, 2010 by certified mail. Letters state that the only way to determine if the incorrect product is contained in the carton is to open the box. Distributors are asked to inspect all Diathermy Cables in their possession with order code 3508M or 3405M to ensure that the correct cable is inside. The number of mislabeled product is to be recorded on the Questionnaire for Distributors, and then mislabeled product is to be destroyed by cutting the product in half. The questionnaires include an area for names of customers stating that the distributor will contact them, or requesting that Unomedical contact them directly. Copies of the correction notice and questionnaire for end users are to be forwarded to all customers, asking them to complete the questionnaire and return it to the distributors. Once received by the distributors, end users can discard the cables by cutting them in half. All completed forms should be returned to Unomedical and local reps are to be contacted to arrange for replacement of mislabeled stock and/or credits.
- Quantity
- 5130 cables worldwide, 1270 in US.
- Distribution
- Worldwide distribution.
- Lot, serial or model codes
- Ref code 3508M, Ref Code 3405M, no expiration dates. Lot numbers: 568229, 568588, 568784, 569128, 620731, 621058, 621143, 621453, 621608, 622599, 622890.
- 510(k) numbers
- ["K982130"]
- PMA numbers
- not on file
- Product code
- GEI
- 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