FDA recall Z-1723-2019

Cook Inc. · Class II · device

Product

Pericardiocentesis Catheter Tray, RPN C-PCYS-850, Order # G03284

Reason for recall

Affected products may have been manufactured with the catheter distal end hole too small

Distribution

Domestically: OH; Internationally: CANADA, SPAIN, ITALY, BELGIUM, GERMANY, UNITED ARAB EMIRATES, GREECE, SWITZERLAND, OMAN, MONACO, SAUDI ARABIA, AUSTRALIA, HONG KONG, INDIA & KOREA

Key facts

Status: Terminated
Initiation date: 2019-04-09
Report date: 2019-06-12
Termination date: 2020-04-28
Voluntary/Mandated: Voluntary: Firm initiated
Location: Bloomington, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1723-2019