Device product
Dover" 100% SILICONE 400ML U/M TEMP SENSE FOLEY TRAY, LL, 18 FR (6.0 MM), 5CC, 2000ML DRAIN BAG, CSD
Z-1051-2024
Product summary
- Event
- Event 93551
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 36300 units
- Official record key
device-enforcement:Z-1051-2024
Official wording
Reason: Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
Code information: 7946, UDI/DI 20884521029559 (cs), 10884521029552 (ea), Lot Numbers: 2222832064, 2301031864, 2317001864, 2209526164, 2215827064, 2317731864, 2305204964, 2305205064, 2210226764, 2208817764
Distribution pattern: US and EMEA, Japan, Latin America
Derived failure modes
-
Unknown
Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.