Bulk 16 FR Valved PTFE Sheath/Dilator, Part Number 10614-011
- Company
- Medamicus, Inc
- Recall Initiated
- June 6, 2003
- Posted
- July 2, 2003
- Terminated
- July 2, 2004
- Recall Number
- Z-0968-03
- Firm Location
- Plymouth, MN
Reason for Recall
Stability testing, after accelerated aging of the device, showed that the handle of device did not meet strength specifications.
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.
Lot / Code Info
Lot Number W24540
Root Cause
Other
Action Taken
The consignees were sent recall letters, dated June 6, 2003 or June 20, 2003, that requested the return of the products.
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