Tracheostomy Supply Kits Recalled for Defective Components
Cardinal Health is recalling 661,560 tracheostomy kits because they were manufactured with components that were subsequently recalled by another manufacturer.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I medical device recall. The agency's classification requires a minimum Severe rating per the severity rubric, regardless of whether specific injuries have been reported.
Plain-English summary
Cardinal Health 200, LLC is recalling TRACH KIT W/HYDROGEN & SALI (REF 47802), convenience kits designed for tracheostomy care, because they were manufactured with components that were subsequently recalled by Nurse Assist.
Approximately 661,560 units were distributed in the United States, EMEA, Japan, and Latin America. Multiple lot numbers are affected, including 2201103364, 2201103464, 2201804164, and others. Complete lot information is available from the manufacturer.
Users and healthcare facilities in possession of affected kits should contact Cardinal Health for guidance on returns or replacements.
The recalled product
- Product
- TRACH KIT W/HYDROGEN & SALI
- Manufacturer
- Cardinal Health 200, LLC
- Hazard
- Affected units
- 661,560
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- REF 47802
- Lot Numbers: 2201103364
- 2201103464
- 2201804164
- 2201804264
- 2204627064
- 2204627364
- 2204801164
- 2205309664
- 2205309764
- 2206020664
- 2206020764
- 2206731664
- 2206731764
- 2208117464
- 2208117564
- 2208828064
- 2208828164
- 2212326364
- 2213014664
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 10 recalled by Cardinal Health 200, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 10 products in this recall →Related recalls
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