Z-0315-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- November 22, 2023
- Initiation Date
- September 21, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 134 units
Product Description
Regard CV PK, Item Numbers a) 880289014, b) 880289015; cardiovascular convenience kit
Reason for Recall
Specific Regard kits contain the Gentige Chest Drain Products being recalled by Gentige. The Instructions for Use (IFU) for the chest drains do not provide sufficient precaution instruction for proper set up of catheter(s) and patient tube connections with single collection chamber chest drains.
Distribution Pattern
MO
Code Information
a) UDI/DI 10194717111702, Lot Numbers: 94114, 95436; b) UDI/DI 10194717117049, Lot Numbers: 96442