Centurion Sterile Trach Brush Recalled Due to Weak Seal
Medline Industries is recalling 1700 Centurion Sterile Trach Brush devices due to a potential weak seal that may breach product sterility if the seal fails. The defect may not be obvious to users.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a sterile medical device with a theoretical hazard (potential sterility breach) and no reported illnesses or injuries. Per the rubric, recalls with theoretical hazards score at most High (3).
Plain-English summary
Medline Industries, LP is recalling the Centurion STERILE TRACH BRUSH (Product Code 6225ST) due to a weak seal defect. This affects 1700 units distributed worldwide, including the United States, Panama, and Canada.
The product may have a weak seal that could result in a breach of sterility if the seal fails. A loss of sterility may allow contamination of the brush. The weak seal may not be detectable by all users.
The affected lot number is 2023021090. Units can be identified by UDI/DI 50653160004750 (case) or 00653160004755 (each).
The recalled product
- Product
- Centurion STERILE TRACH BRUSH, Product Code 6225ST
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- weak-seal
- sterility-breach
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 (3)
- UDI/DI 50653160004750 (case)
- 00653160004755 (each)
- Lot Numbers: 2023021090
Distribution
Distributed nationwide across the United States.
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