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.
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
