FDA-Device2013-01-09Class III
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.
St Jude Medical Inc
Hazard
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.
Sold states
US Distribution only including the states of FL, KY and OK.
Affected count
26
Manufactured in
177 E County Road B, N/A, Saint Paul, MN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0617-2013Don't want to check this manually?
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