FDA-Device2024-02-28Class I
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
Hazard
Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
Sold states
US and EMEA, Japan, Latin America
Affected count
924 units
Manufactured in
3651 Birchwood Dr, N/A, Waukegan, IL, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1052-2024More Cardinal Health 200, LLC recalls
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