FDA Enforcement
Class I
Ongoing
Dover" 100% SILICONE 400ML U/M TEMP SENSE FOLEY TRAY, LL, 18 FR (6.0 MM), 5CC, 2000ML DRAIN BAG, CSD
Recall: Z-1051-2024
·
Reported February 28, 2024
Enforcement
- Recall Number
- Z-1051-2024
- 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 400ML U/M TEMP SENSE FOLEY TRAY, LL, 18 FR (6.0 MM), 5CC, 2000ML DRAIN BAG, CSD
Reason
Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
Code Info
7946, UDI/DI 20884521029559 (cs), 10884521029552 (ea), Lot Numbers: 2222832064, 2301031864, 2317001864, 2209526164, 2215827064, 2317731864, 2305204964, 2305205064, 2210226764, 2208817764
Distribution
US and EMEA, Japan, Latin America
Quantity
36300 units