FDA-Device2015-01-07Class II
Cryogenic probe for cardiac ablation surgery, packaged individually in Tyvek pouches Product Usage: Cryogenic probe for cardiac ablation surgery. The CryoICE cryoablation probe is a sterile, single use device intended to use in the cryosurgical treatment of cardiac arrhythmias. The probe freezes target tissues, creating an inflammatory response (cryo-necrosis) that blocks the electrical conduction pathway.
Atricure Inc
Hazard
Affected product may have compromised sterility due to packaging defects. It was determined that some mishandling of the product during the packaging process could inadvertently damage the sterile barrier.
Sold states
Worldwide Distribution - US Nationwide and the countries of: Canada, ITALY, NETHERLANDS, CZECH REPUBLIC, AUSTRIA, GERMANY, BELGIUM, Hong Kong, SPAIN, UNITED KINGDOM (GREAT BRITAIN), UNITED KINGDOM, JAPAN, FRANCE, FINLAND, LUXEMBOURG, Korea, SWITZERLAND, SWEDEN, Malaysia, ISRAEL, NORWAY, AUSAtralia, COLOMBIA, TURKEY, Thailand, SOUTH KOREA, SAUDI ARABIA, TAIWAN, SOUTH AFRICA, and DENMARK. The affected product was also distributed to 17 government consignees.
Affected count
19,190 units
Manufactured in
6217 Centre Park Drive, N/A, West Chester, OH, United States
Products
Cryogenic probe for cardiac ablation surgery, packaged individually in Tyvek pouches Product Usage: Cryogenic probe for cardiac ablation surgery. The CryoICE cryoablation probe is a sterile, single use device intended to use in the cryosurgical treatment of cardiac arrhythmias. The probe freezes target tissues, creating an inflammatory response (cryo-necrosis) that blocks the electrical conduction pathway.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0895-2015Don't want to check this manually?
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