Medline Bronchoscopy Tray Components Recalled for Potential Lack of Sterility
Medline Industries is recalling certain Nurse Assist components used in Bronchoscopy Trays due to potential lack of sterility. Affected irrigation solutions and saline flush syringes may be non-sterile.
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 classified this as a Class I recall for medical devices. Per the severity rubric, FDA Class I recalls must receive a minimum severity score of 4. Although no illnesses or injuries are reported in the source, potential non-sterility in medical irrigation solutions used in clinical procedures represents a serious infection risk.
Plain-English summary
Medline Industries, LP is recalling specific lots of components used in certain Bronchoscopy Trays manufactured with Nurse Assist products. The recalled items include 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP, and Saline Flush Syringe. The affected lot numbers are 2022022550, 2022050550, and 2022051050.
The recall was issued due to the potential lack of sterility in these components. The solutions may be non-sterile, which could result in infections during medical procedures.
The affected products have been distributed nationwide throughout the United States, including Puerto Rico, and internationally to Canada, the United Arab Emirates, and Panama.
The recalled product
- Product
- MEDLINE BRONCHOSCOPY TRAY, REF DYNDL1350A
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
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 (5)
- UDI/DI 40889942880486 (case)
- 10889942880485 (unit)
- Lot Numbers: 2022022550
- 2022050550
- 2022051050
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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