Tracheostomy care sets recalled for sterility assurance failure
Busse Hospital Disposables is recalling tracheostomy care kits due to failed sterility assurance. The affected product cannot guarantee required sterility levels and poses risks of infection and sepsis.
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: This is an FDA Class I recall for failure of sterility assurance in a sterile medical device. Although no infections or deaths have been reported, the manufacturer cannot guarantee the required sterility level, creating theoretical risk of serious infections including sepsis and death. FDA Class I recalls are classified as Severe or Critical; with no realized harm reported, this meets the Severe threshold.
Plain-English summary
Busse Hospital Disposables, Inc. is recalling tracheostomy care sets with product lots 2210087, 2210165, and 2310361. The products were distributed nationwide in the United States.
The manufacturer identified that these kits cannot guarantee the required sterility assurance level (SAL) of 10^-6. The failure of this sterility assurance creates a risk of contamination.
If used, these kits pose risks of blood stream infections, urinary tract infections, and respiratory infections. In the worst-case scenario, there is risk of sepsis or death.
The recalled product
- Product
- Catalog No. 9251R1, 9251R2, 9251R3 TRACHEOSTOMY CARE SET / STERILE - LATEX FREE
- Manufacturer
- Busse Hospital Disposables, Inc.
- Affected units
- 240
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 (1)
- UDI-DI 00849233011069 Lots 2210087 2210165 2310361
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Busse Hospital Disposables, Inc. 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.
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