Device product

Centurion DISP.UMBILICAL CORD CLAMP CUTTER(CTR300), Product Code 67335

Z-1451-2024

February 23, 2024

Class II

Product summary

Firm: MEDLINE INDUSTRIES, LP - Northfield
Event: Event 94136
Status: Ongoing
Classification: Class II
Quantity: 1350 units
Official record key: device-enforcement:Z-1451-2024

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 00653160349771 (case) 10653160349778 (each), Lot Numbers: 2023111090

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