FDA Device Recall Z-1044-2024

Cardinal Health 200, LLC · Waukegan, IL

Class I — life-threatening Ongoing

Highest impact — Class I device recall — FDA determination that use of, or exposure to, the device will cause serious adverse health consequences or death.

Device

TRACH KIT W/HYDROGEN & SALI

Lot / serial / GTIN: 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

Quantity: 661,560 units

Reason for recall

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

Recall record

Recall number: Z-1044-2024
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: US and EMEA, Japan, Latin America
Recall initiated: 2023-12-04
Classified by FDA Center: 2024-02-16
FDA published: 2024-02-28
Recalling firm: Cardinal Health 200, LLC
Firm location: Waukegan, IL

Operational response

A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.

For the official FDA enforcement record, see FDA's Recall Search.

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