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U.S. Department of Health and Human Services

Class 2 Device Recall Medamicus

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  Class 2 Device Recall Medamicus see related information
Date Initiated by Firm June 06, 2003
Date Posted July 02, 2003
Recall Status1 Terminated 3 on July 02, 2004
Recall Number Z-0968-03
Recall Event ID 26475
510(K)Number K021044  
Product Classification Introducer, Catheter - Product Code DYB
Product Bulk 16 FR Valved PTFE Sheath/Dilator, Part Number 10614-011
Code Information Lot Number W24540
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.
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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