Device product
Pericardiocentesis Catheter Set, RPN C-PCS-850, Order # G03282
Z-1722-2019
Product summary
- Firm
- Cook Inc.
- Event
- Event 82692
- Status
- Terminated
- Classification
- Class II
- Quantity
- 83 kits
- Official record key
device-enforcement:Z-1722-2019
Official wording
Reason: Affected products may have been manufactured with the catheter distal end hole too small
Code information: Lot Numbers 7716007 7703324 NS7703501 NS7703502 NS7703503 NS7704718 NS7704722 NS7704727 NS7704728
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