Z-0315-2024 Class II Ongoing
FDA device recall Z-0315-2024 was initiated by ROi CPS LLC on September 21, 2023 and is designated Class II. 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 prope… The recall status is ongoing. Affected quantity: 134 units.
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