RecallDepth

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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