Device product
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
Z-1052-2024
Product summary
- Event
- Event 93551
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 924 units
- Official record key
device-enforcement:Z-1052-2024
Official wording
Reason: Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
Code information: 1814, UDI/DI 20884521003528 (cs), 10884521003521 (ea), Lot Numbers: 22210206164, 2211627364, 2231919964
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.