FDA recall Z-0596-2024

Product

Regard Dressing change kit, Item Number 800026006

Reason for recall

ROi CPS manufactured and distributed medical convenience kits with an irrigation solution component which was subsequently recalled by the component manufacturer.

Distribution

US Nationwide distribution in the state of Louisiana.

Key facts

Status

Terminated

Initiation date

2023-11-20

Report date

2024-01-10

Termination date

2024-08-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Republic, MO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0596-2024