Recall archive / FDA device enforcement
TRACH KIT W/HYDROGEN & SALI — FDA record Z-1044-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Dec 4, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- TRACH KIT W/HYDROGEN & SALI
- Reason
- Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
- Classification
- Class I
- Recalling firm
- Cardinal Health 200, LLC
- Quantity
- 661,560 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1044-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | REF 47802; Lot Numbers: 2201103364, 2201103464, 2201804164, 2201804264, 2204627064, 2204627364, 2204801164, 2205309664, 2205309764, 2206020664, 2206020764, 2206731664, 2206731764, 2208117464, 2208117564, 2208828064, 2208828164, 2212326364, 2213014664, 2215107664, 2215808564, 2222816264, 2216523964, 2217209464, 2219323864, 2217915264, 2219326264, 2219910964, 2221312264, 2221312164, 2222816164, 2222816364, 2223528364, 2223528464, 2224243164, 2224243264, 2224929764, 2224929864, 2225515664, 2226320664, 2225515764, 2226320764, 2227034464, 2229112364, 2227725164, 2227725264, 2227022264, 2231226564, 2231914264, 2305711364, 2305711464, 2306201964, 2300121564, 2305706564, 2306622764, 2307909364, 2307305764, 2307305664, 2307909464, 2308600464, 2310101364, 2310101464, 2311517164, 2310900364 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US and EMEA, Japan, Latin America
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Feb 28, 2024
- Recall initiation date
- Dec 4, 2023
- Center classification date
- Feb 16, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.