Device product
Pericardiocentesis Catheter Tray, RPN C-PCYS-850, Order # G03284
Z-1723-2019
Product summary
- Firm
- Cook Inc.
- Event
- Event 82692
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2 kits
- Official record key
device-enforcement:Z-1723-2019
Official wording
Reason: Affected products may have been manufactured with the catheter distal end hole too small
Code information: Lot Number NS7726043
Distribution pattern: Domestically: OH; Internationally: CANADA, SPAIN, ITALY, BELGIUM, GERMANY, UNITED ARAB EMIRATES, GREECE, SWITZERLAND, OMAN, MONACO, SAUDI ARABIA, AUSTRALIA, HONG KONG, INDIA & KOREA
Derived failure modes
-
Unknown
Affected products may have been manufactured with the catheter distal end hole too small