Z-1722-2019 Class II Terminated
FDA device recall Z-1722-2019 was initiated by Cook Inc. on April 9, 2019 and is designated Class II. Reason for recall: Affected products may have been manufactured with the catheter distal end hole too small The recall status is terminated (terminated April 28, 2020). Affected quantity: 83 kits.
Recall Details
- Product Type
- Devices
- Report Date
- June 12, 2019
- Initiation Date
- April 9, 2019
- Termination Date
- April 28, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 83 kits
Product Description
Pericardiocentesis Catheter Set, RPN C-PCS-850, Order # G03282
Reason for Recall
Affected products may have been manufactured with the catheter distal end hole too small
Distribution Pattern
Domestically: OH; Internationally: CANADA, SPAIN, ITALY, BELGIUM, GERMANY, UNITED ARAB EMIRATES, GREECE, SWITZERLAND, OMAN, MONACO, SAUDI ARABIA, AUSTRALIA, HONG KONG, INDIA & KOREA
Code Information
Lot Numbers 7716007 7703324 NS7703501 NS7703502 NS7703503 NS7704718 NS7704722 NS7704727 NS7704728