Skip to content
Recall Observatory FDA recall evidence

Device product

Centurion STERILE COTTON DENTAL ROLLS 6/PK, Product Code 9125ST6

Z-1429-2024

February 23, 2024

Class II

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 94136
Status
Ongoing
Classification
Class II
Quantity
100 units
Official record key
device-enforcement:Z-1429-2024

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 10653160129257 (case), 00653160129250 (each), Lot Numbers: 2023022290, 2023042490

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