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Recall Observatory FDA recall evidence

Device product

1,5L MED-SOFT SINGLE LINER WITH SOLIDIFIER, REF OR1920PG

Z-2699-2024

March 22, 2024

Class II

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 94356
Status
Ongoing
Classification
Class II
Quantity
316125 units
Official record key
device-enforcement:Z-2699-2024

Official wording

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

Code information: UDI/DI 20888277660103 (package), 0888277DC265NSKX (unit), Lot Numbers: 670220511, 670220622, 670220628, 670220706, 670220720, 670220801, 670220805, 670220907, 670220912, 670221020, 670221115, 670221128, 670221205, 670221213, 670221219, 670221223, 670230105, 670230213, 670230308, 670230322, 670230424, 670230530, 670230601

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.