Z-1565-2020 Class II Terminated
FDA device recall Z-1565-2020 was initiated by Cook Inc. on March 6, 2020 and is designated Class II. Reason for recall: The printed expiration dates are incorrect. The recall status is terminated (terminated December 18, 2020). Affected quantity: 25.
Recall Details
- Product Type
- Devices
- Report Date
- April 1, 2020
- Initiation Date
- March 6, 2020
- Termination Date
- December 18, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 25
Product Description
Pericardiocentesis Set, Irrigation Catheter, Reference Part Number C-PCS-700-TORONT0-042997, Order Number G10643
Reason for Recall
The printed expiration dates are incorrect.
Distribution Pattern
The products were distributed to the following US states: CO, DE, MD, MN, NC, NV, and WV. The products were distributed to the following foreign countries: Canada.
Code Information
Lot Number 10119247; UDI: (01)00827002106437(17)921110(10)10119247