Z-1142-2010

Neutralect Diathermy Cable, Unomedical Ltd., Ref code 3508M, and Ref Code 3405M

Name: Z-1142-2010 Neutralect Diathermy Cable, Unomedical Ltd., Ref code 3508M, and Ref Code 3405M
Creator: ConvaTec
Published: 2010-01-22
License: https://open.fda.gov/license/

ConvaTec Limited / initiated 2010-01-22 / Terminated / root cause: labeling and UDI

FDA source

ConvaTec began a recall of Neutralect Diathermy Cable, Unomedical Ltd., Ref code 3508M, and Ref Code 3405M on 2010-01-22. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1142-2010
Status: Terminated
Initiated: 2010-01-22
Posted: 2010-03-16
Terminated: 2010-06-10
Recalling firm: ConvaTec Limited
Product: Neutralect Diathermy Cable, Unomedical Ltd., Ref code 3508M, and Ref Code 3405M.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: 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 tag: labeling and UDI
FDA 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 in commerce: 5130 cables worldwide, 1270 in US.
Distribution: Worldwide distribution.
Product codes and lots: Ref code 3508M, Ref Code 3405M, no expiration dates. Lot numbers: 568229, 568588, 568784, 569128, 620731, 621058, 621143, 621453, 621608, 622599, 622890.

Product code GEI

K982130Class IIReturn Electrode Clamp Shell Cord Model Rc 201New Deantronics, Ltd. / cleared 1998-08-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)