Fast-Cath Transseptal Guiding Introducer, 90, 8F, REF 406586, Length 60 cm, Sterile EO, Rx only, St. Jude Medical, 14901 DeVeau Place, Minnetonka, MN 55343 Indicated for introducing various cardiovascular catheters into the left side of the heart through the interatrial septum.
FDA Recall Z-0617-2013 · Posted 2012-12-28
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Recalling FirmSt Jude Medical Inc
Recall StatusTerminated
Product CodeDYB
Date Initiated2012-03-28
Date Terminated2013-07-12
Product Quantity26
Reason for Recall
St. Jude Medical is recalling a single batch of Fast Cath Transseptal Guiding Introducers which was packaged as a 180 degree curve style introducer instead of a 90 degree curve style introducer as indicated on the labeling.
Firm Action
St Jude Medical hand delivered the" Product Recall" letter dated March 27, 2012, to the affected customers on April 5, 2012, and March 28, 2012. The letter identified the product, the problem and the action needed to be taken by the customer.
The returned devices and those not distributed were quarantined at the SJM Minnetonka distribution center until their destruction.
Customers were requested to to complete and return the reconciliation form.
Further questions please call (651) 756-6526
Root Cause
Process control
Distribution Pattern
US Distribution only including the states of FL, KY and OK.
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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