ROi CPS LLC: Regard CV PK, Item Numbers a) 880289014, b) 880289015; cardiovascular convenience kit

Hazard

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.

Details from the source

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: MO Quantity: 134 units Lot/code info: a) UDI/DI 10194717111702, Lot Numbers: 94114, 95436; b) UDI/DI 10194717117049, Lot Numbers: 96442

UPC codes

10194717111702, 10194717117049

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.