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Recall Observatory FDA recall evidence

Device product

1,5L MED-SOFT LINER W/ 6MMX1,8M TUB. & ADULT VC, REF OR53926

Z-2697-2024

March 22, 2024

Class II

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 94356
Status
Ongoing
Classification
Class II
Quantity
88703 units
Official record key
device-enforcement:Z-2697-2024

Official wording

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

Code information: UDI/DI 40888277422279 (package), 0888277DC265NSKX (unit), Lot Numbers: 670220512, 670220609, 670220621, 670220629, 670220712, 670220803, 670220815, 670220914, 670221009

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.