FDA recall Z-3159-2024

ROi CPS LLC · Class II · device

Product

regard Clinical Packaging Solutions, HT00376I - SPECIAL PROCEDURE, Item Number 800223009

Reason for recall

Medical convenience kits were distributed with Merit syringes (manufactured by Jiangsu Shenli Medical Production) which were subsequently recalled.

Distribution

US Nationwide distribution in the state of North Carolina.

Key facts

Status
Ongoing
Initiation date
2024-07-24
Report date
2024-09-25
Voluntary/Mandated
Voluntary: Firm initiated
Location
Republic, MO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3159-2024