FDA-Device2019-06-12Class II
Pericardiocentesis Catheter Set, RPN C-PCS-850, Order # G03282
Cook Inc.
Hazard
Affected products may have been manufactured with the catheter distal end hole too small
Sold states
Domestically: OH; Internationally: CANADA, SPAIN, ITALY, BELGIUM, GERMANY, UNITED ARAB EMIRATES, GREECE, SWITZERLAND, OMAN, MONACO, SAUDI ARABIA, AUSTRALIA, HONG KONG, INDIA & KOREA
Affected count
83 kits
Manufactured in
750 N Daniels Way, Bloomington, IN, United States
Products
Pericardiocentesis Catheter Set, RPN C-PCS-850, Order # G03282
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1722-2019Don't want to check this manually?
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