Z-1052-2024 Class I Ongoing
FDA device recall Z-1052-2024 was initiated by Cardinal Health 200, LLC on December 4, 2023 and is designated Class I. Reason for recall: Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist. The recall status is ongoing. Affected quantity: 924 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 28, 2024
- Initiation Date
- December 4, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 924 units
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.
Distribution Pattern
US and EMEA, Japan, Latin America
Code Information
1814, UDI/DI 20884521003528 (cs), 10884521003521 (ea), Lot Numbers: 22210206164, 2211627364, 2231919964