FDA recall Z-1052-2024

Product

Dover" 100% SILICONE FOLEY TRAY, NEEDLELESS, 14 FR (4.7 MM), 5 CC, 2000 ML DRAIN BAG, DRAIN SPOUT; Dover" HYDROGEL COATED LATEX FOLEY CATHETER KIT, 5 CC, 2-WAY, 14 FR (4.7 MM), 10 CC WATER SYRINGE

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-1052-2024