Device product

1,5L MED-SOFT LINER W/ 6MMX3M TUB. & ADULT VC, REF OR53929

Z-2698-2024

March 22, 2024

Class II

Product summary

Firm: MEDLINE INDUSTRIES, LP - Northfield
Event: Event 94356
Status: Ongoing
Classification: Class II
Quantity: 35900 units
Official record key: device-enforcement:Z-2698-2024

Official wording

Reason: A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.

Code information: UDI/DI 40888277422286 (package), 0888277DC265NSKX (unit), Lot Numbers: 670220505, 670220609, 670220621, 670220720, 670220804, 670220926, 670220928, 670221024, 670221115, 670221227, 670230109, 670230210, 670230424

Distribution pattern: Worldwide - US Nationwide and the countries of Panama, Mexico, Canada, Qatar, El Salvador, Oman, Colombia, Singapore.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.