Device product

Centurion FCP MAGILL CATH 7.5 IN PED (67575), Product Code 67575

Z-1428-2024

February 23, 2024

Class II

Product summary

Firm: MEDLINE INDUSTRIES, LP - Northfield
Event: Event 94136
Status: Ongoing
Classification: Class II
Quantity: 480 units
Official record key: device-enforcement:Z-1428-2024

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 00653160352054 (case), 10653160352051 (each), Lot Numbers: 2023071390

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