FDA-Device2014-10-15Class II
Biosense Webster's Reprocessed SOUNDSTAR¿ eco Diagnostic Ultrasound Catheters, Catalog Nos: M-5723-115, Model Number BIO10438577.
STERILMED, INC.
Hazard
Sterilmed, a division of Johnson & Johnson Medical NV/SA (Sterilmed), has become aware of an issue affecting certain lots of Reprocessed SOUNDSTAR® eco Diagnostic Ultrasound Catheters for which Sterilmed is the reprocessor and Biosense Webster is the distributor. Sterilmed determined that the units of these lots were incorrectly processed and as a result when the affected catheter is conne
Sold states
US Distribution including the states of WA and CA.
Affected count
22
Manufactured in
11400 73rd Ave N, Maple Grove, MN, United States
Products
Biosense Webster's Reprocessed SOUNDSTAR¿ eco Diagnostic Ultrasound Catheters, Catalog Nos: M-5723-115, Model Number BIO10438577.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0059-2015Don't want to check this manually?
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