FDA recall Z-1051-2024

Cardinal Health 200, LLC · Class I · device

Product

Dover" 100% SILICONE 400ML U/M TEMP SENSE FOLEY TRAY, LL, 18 FR (6.0 MM), 5CC, 2000ML DRAIN BAG, CSD

Reason for recall

Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.

Distribution

US and EMEA, Japan, Latin America

Key facts

Status
Ongoing
Initiation date
2023-12-04
Report date
2024-02-28
Voluntary/Mandated
Voluntary: Firm initiated
Location
Waukegan, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1051-2024