Class I — Cardinal Health 200, LLC
| Recalling firm | Cardinal Health 200, LLC |
|---|---|
| Registered facility | View this company's 35 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class I |
| Status | Ongoing |
| Reason | Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist. |
| Product | Dover URINE METER ADD-A-FOLEY TRAY, 200 ML, NEEDLE SAMPLING PORT, DRAIN TUBE, PREP TRAY; Dover UNIVERSAL TRAY, 1000 ML BASIN, PVP SWAB STICKS, PREPPING COMPONENTS, 30 CC PRE-FILLED SYRINGE; Dover URINE DRAINAGE ADD-A-FOLEY TRAY, NEEDLE SAMPLING, A/R, DRAIN TUBE, PREP TRAY, 30 ML SYRINGE; Dover HYDROGEL COATED LATEX FOLEY TRAY 16 FR (5.3 MM), 5 CC, 2000 ML DRAINAGE BAG, DRAIN TUBE; Dover 100% SILICONE FOLEY TRAY, NEEDLE PORT, 18 FR (6.0 MM), 5 CC, 2000 ML DRAIN BAG, DRAIN SPOUT; Dover 100% SILICONE FOLEY TRAY, NEEDLE PORT, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG, DRAIN SPOUT; Dover SILICONE COA… |
| Quantity | 435060 units |
| Distribution | US and EMEA, Japan, Latin America |
| Initiated | 2023-12-04 |
| Classified | 2024-02-16 |
| Recall number | Z-1046-2024 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — Cardinal Health 200, LLC (Z-1046-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/93551/
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