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Recall Observatory FDA recall evidence

Device product

Centurion STERILE TRACH BRUSH, Product Code 6225ST

Z-1427-2024

February 23, 2024

Class II

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 94136
Status
Ongoing
Classification
Class II
Quantity
1700
Official record key
device-enforcement:Z-1427-2024

Official wording

Reason: Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.

Code information: UDI/DI 50653160004750 (case), 00653160004755 (each), Lot Numbers: 2023021090

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Panama, Canada.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    weak seal
  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    breach of sterility