RecallDepth

SCIPRO Flexible Stone Dislodger and Retrieval Set Catalog # SP3000146ST

Company
Scion Cardio-Vascular, Inc.
Recall Initiated
May 23, 2003
Posted
February 27, 2004
Terminated
May 7, 2004
Recall Number
Z-0554-04
Quantity
28
Firm Location
Miami, FL

Reason for Recall

Possible difficulty for the user in opening the stone retrieval basket.

Distribution

Product was distributed 12 hospitals and clinics in NJ, RI, NY, PA, VA, KY, TX, OH, TX AND FL.

Lot / Code Info

Lot # OML30403-01

Root Cause

Other

Action Taken

The firm mailed a recall letter on May 23, 2003 with a pre-paid FedEx shipment label to the consignees requesting that they return the indicated product and lot number. The firm recieved a response from each consignee and accounted for all shipped product by 6/24/2003.

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