Retiro De Equipo (Recall) de Device Recall Neutralect

Recall

54363

Class 2

Z-1142-2010

2010-01-22

2010-03-16

Terminated

United States

2010-06-10

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=88334

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.

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.