Data Foundry

Medical device recalls 2024

TRACH KIT W/HYDROGEN & SALI — Class I medical device recall Z-1044-2024

Ongoing recall by Cardinal Health 200, LLC, reported 2024-02-28. Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse A

Recall numberZ-1044-2024
Product typeMedical device
ClassificationClass I
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmCardinal Health 200, LLC, Waukegan, IL, United States
Recall initiated2023-12-04
Classified2024-02-16
Reported by FDA2024-02-28
Countries outside the USJP
Quantity661,560 units
Lot numbers2201103364, 2201103464, 2201804164, 2201804264, 2204627064, 2204627364, 2204801164, 2205309664, 2205309764, 2206020664, 2206020764, 2206731664, 2206731764, 2208117464, 2208117564, 2208828064, 2208828164, 2212326364, 2213014664, 2215107664, 2215808564, 2216523964, 2217209464, 2217915264, 2219323864, 2219326264, 2219910964, 2221312164, 2221312264, 2222816164, 2222816264, 2222816364, 2223528364, 2223528464, 2224243164, 2224243264, 2224929764, 2224929864, 2225515664, 2225515764 and 24 more
Model numbers47802

Product

TRACH KIT W/HYDROGEN & SALI

Reason for recall

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

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1044-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.