Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recallsee related information
Date Initiated by FirmMay 23, 2003
Date PostedJune 17, 2003
Recall Status1 Terminated 3 on July 02, 2004
Recall NumberZ-0931-03
Recall Event ID 26330
Product Classification Stimulator, Nerve, Transcutaneous, For Pain Relief - Product Code GZJ
ProductLine Powered RePak, Model Number 1785S
Code Information 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.
FEI Number 2126518
Recalling Firm/
Manufacturer		 Rehabilicare
1811 Old Hwy 8
New Brighton MN 55112
For Additional Information ContactGary L. Moore
651-638-0437
Manufacturer 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 Determined
Cause 2		Other
ActionRecall 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 Commerce618 Line Powered RePaks
DistributionNationwide in the United States
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
-
-