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Recall Observatory FDA recall evidence

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

December 04, 2023

Class I

Product summary

Firm
Cardinal Health 200, LLC
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

    reason.no_named_rule · v1.0.0

    Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.