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Recall Observatory FDA recall evidence

Device product

LINER, SOFT, SUCTION CANISTER, 1500CC, REF OR929K

Z-2695-2024

March 22, 2024

Class II

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 94356
Status
Ongoing
Classification
Class II
Quantity
Unavailable
Official record key
device-enforcement:Z-2695-2024

Official wording

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

Code information: UDI/DI 40888277276209 (package), 10888277276208 (unit), Lot Numbers: 670220928, 670220928, 670221020, 670221010, 670221121, 670220928, 670221128, 670221128, 670221128, 670230317, 670230419, 670230419, 670230317, 670230419

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.