FDA recall Z-0315-2024

Product

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

MO

Key facts

Status

Ongoing

Initiation date

2023-09-21

Report date

2023-11-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Republic, MO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0315-2024