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Recall Observatory FDA recall evidence

Device product

Regard CV PK, Item Numbers a) 880289014, b) 880289015; cardiovascular convenience kit

Z-0315-2024

September 21, 2023

Class II

Product summary

Firm
ROi CPS LLC
Event
Event 93204
Status
Ongoing
Classification
Class II
Quantity
134 units
Official record key
device-enforcement:Z-0315-2024

Official wording

Reason: 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.

Code information: a) UDI/DI 10194717111702, Lot Numbers: 94114, 95436; b) UDI/DI 10194717117049, Lot Numbers: 96442

Distribution pattern: MO

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.