Date Initiated by Firm |
June 06, 2003 |
Date Posted |
July 02, 2003 |
Recall Status1 |
Terminated 3 on July 02, 2004 |
Recall Number |
Z-0963-03 |
Recall Event ID |
26475 |
510(K)Number |
K021044
|
Product Classification |
Introducer, Catheter - Product Code DYB
|
Product |
Medamicus FlowGuard 15FR Valved Peelable Introducer Kit, Catalog Number 10532-010 |
Code Information |
Lot Number W23155 |
Recalling Firm/ Manufacturer |
MedAmicus,Inc 15301 Highway 55 West Plymouth MN 55447
|
For Additional Information Contact |
Karyl Haskell 763-577-2257
|
Manufacturer Reason for Recall |
Stability testing, after accelerated aging of the device, showed that the handle of device did not meet strength specifications.
|
FDA Determined Cause 2 |
Other |
Action |
The consignees were sent recall letters, dated June 6, 2003 or June 20, 2003, that requested the return of the products. |
Quantity in Commerce |
14 units |
Distribution |
The products were distributed to 4 consignees in Georgia, Missouri, New York and North Carolina. Most of the product was shipped to a distributor in New York which probably shipped to other states. There was no direct distribution to foreign or U.S Government accounts. |
Total Product Life Cycle |
TPLC 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.
|
510(K) Database |
510(K)s with Product Code = DYB and Original Applicant = WOLFE TORY MEDICAL, INC.
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