Medline Tracheal Care Trays Recalled Due to Sterility Concerns
Medline Industries is recalling 385,028 tracheostomy care trays due to potential sterility issues with certain components. The kits were distributed nationwide and internationally.
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 FDA Class I recall meets the Severe (score 4) threshold per the recall rubric, which requires a minimum rating of 4 for all Class I recalls. The potential sterility failure in components for critical airway care applications justifies this rating.
Plain-English summary
Medline Industries, LP is recalling 385,028 Tray Trach Basic Solution kits due to potential sterility issues. The kits contain components supplied by Nurse Assist, including 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP, and Saline Flush Syringes, that may lack proper sterility.
Nurse Assist issued the recall due to the potential lack of sterility in these components, which could result in the solution being non-sterile. The affected lot numbers are: 22DBO136, 22EBE146, 22HBP422, 22IBN508, 22IBS920, 22KBS241, 23BBE594, 23CBN979, 23EBT594, and 23IBA884.
The kits have been distributed nationwide throughout the United States, as well as in Puerto Rico, Canada, the United Arab Emirates, and Panama.
The recalled product
- Product
- MEDLINE TRAY TRACH BASIC SOLUTION, REF DYND40511
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 385,028
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 (12)
- UDI/DI 40888277597922 (case)
- 10888277597921 (unit)
- Lot Numbers: 22DBO136
- 22EBE146
- 22HBP422
- 22IBN508
- 22IBS920
- 22KBS241
- 23BBE594
- 23CBN979
- 23EBT594
- 23IBA884
Distribution
Part of a larger recall action
This product is one of 49 recalled by MEDLINE INDUSTRIES, LP - Northfield 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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