FDA Enforcement
Class I
Ongoing
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
Recall: Z-1052-2024
·
Reported February 28, 2024
Enforcement
- Recall Number
- Z-1052-2024
- Event ID
- 93551
- Classification
- Class I
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Cardinal Health 200, LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- February 28, 2024
- Initiation Date
- December 4, 2023
- Classification Date
- February 16, 2024
- Address
- 3651 Birchwood Dr, N/A, Waukegan, IL, 60085-8337, United States
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
Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
Code Info
1814, UDI/DI 20884521003528 (cs), 10884521003521 (ea), Lot Numbers: 22210206164, 2211627364, 2231919964
Distribution
US and EMEA, Japan, Latin America
Quantity
924 units