AngioDynamics 14F EmboSafe Valved Peelable Introducer, 5 units per shelf box, Catalog number 06507601
- Company
- Medamicus, Inc
- Recall Initiated
- June 6, 2003
- Posted
- July 2, 2003
- Terminated
- July 2, 2004
- Recall Number
- Z-0964-03
- Quantity
- 955 boxes
- 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 Numbers W24305, W24310, and W24311
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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