Dover" 100% SILICONE FOLEY TRAY, NEEDLELESS, 14 FR (4.7 MM), 5 CC, 2000 ML DRAIN BAG, DRAIN SPOUT...
FDA Recall #Z-1052-2024 — Class I — December 4, 2023
Product Description
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.
Recalling Firm
Cardinal Health 200, LLC — Waukegan, IL
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Devices
Product Quantity
924 units
Distribution
US and EMEA, Japan, Latin America
Code Information
1814, UDI/DI 20884521003528 (cs), 10884521003521 (ea), Lot Numbers: 22210206164, 2211627364, 2231919964
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.