SCIPRO Flexible Stone Dislodger and Retrieval Set Catalog # SP3000146ST
FDA Recall Z-0554-04 · Posted 2004-02-27
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Recalling FirmScion Cardio-Vascular, Inc.
Recall StatusTerminated
Product CodeFGO
Date Initiated2003-05-23
Date Terminated2004-05-07
Product Quantity28
Reason for Recall
Possible difficulty for the user in opening the stone retrieval basket.
Firm Action
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.
Root Cause
Other
Distribution Pattern
Product was distributed 12 hospitals and clinics in NJ, RI, NY, PA, VA, KY, TX, OH, TX AND FL.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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