Tracheostomy care kits recalled for sterility assurance failure
Busse Hospital Disposables is recalling tracheostomy care kits containing Nurse Assist Sterile Normal Saline because the required sterility assurance level cannot be guaranteed. Contaminated products could cause serious infections including bloodstream, respiratory, and urinary tract infections, or 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: FDA Class I classification requires a minimum severity score of 4. The hazard includes risk of serious infections (bloodstream, respiratory, urinary tract) and potential sepsis or death, but no illnesses or deaths have been reported as already occurring.
Plain-English summary
Busse Hospital Disposables, Inc. is recalling kits containing affected lots of Nurse Assist Sterile 0.9% Normal Saline. The recall affects 705 units distributed nationwide with the following lot numbers: 2210099, 2210135, 2210337, 2210377, 2310181, 2310233, and 2310291.
The manufacturer identified that the required sterility assurance level (SAL) of 10^-6 cannot be guaranteed for these products. This means the products may not be adequately sterilized.
If contaminated products are used, patients could develop bloodstream infections, urinary tract infections, or respiratory infections. In the worst-case scenario, patients could develop sepsis or experience death.
The recalled product
- Product
- Catalog No. 800 TRACHEOSTOMY CARE TRAY - STERILE -LATEX FREE
- Manufacturer
- Busse Hospital Disposables, Inc.
- Affected units
- 705
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.
See all 3 products in this recall →Related recalls
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