Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0931-03

Line Powered RePak, Model Number 1785S

Rehabilicare, Inc. / initiated 2003-05-23 / Terminated

Rehabilicare began a recall of Line Powered RePak, Model Number 1785S on . The reason FDA records is "If there was a short, excessive heat could have been generated in the transformer due to the use of the wrong fuse". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0931-03
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Rehabilicare, Inc.
Product
Line Powered RePak, Model Number 1785S
Product code
GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Reason for recall
If there was a short, excessive heat could have been generated in the transformer due to the use of the wrong fuse.
FDA root cause
Other
Action
Recall letters dated May 21, 2003 requested that consignees return the product and a response form to the firm. Distributors were requested to recall the product from their customers.
Quantity in commerce
618 Line Powered RePaks
Distribution
Nationwide in the United States
Product codes and lots
Line Powered RePaks, Model Number 1785S, distributed from April 9, 2003 to May 7, 2003 are to be recovered. Between 04/09/03 and 05/07/03, 618 Line Powered RePaks (Model 1785S) were shipped.