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Recall Observatory FDA recall evidence

Device product

1500ML SOFT LINER, 1/4X6 TBG NS, REF OR926K

Z-2696-2024

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-2696-2024

Official wording

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

Code information: UDI/DI 40888277276223 (package), 10888277276222 (unit), Lot Numbers: 670220510, 670220607, 670220607, 670220701, 670220701, 670220701, 670220727, 670220721, 670220727, 670220727, 670220825, 670220825, 670221115, 670220915, 670220825, 670220915, 670220915, 670220928, 670220928, 670220928, 670221024, 670220928, 670221024, 670221220, 670221220, 670221124, 670221124, 670221213, 670221202, 670221202, 670221222, 670221222, 670221222, 670230206, 670230206, 670230215, 670230417, 670230331, 670230417, 670230508, 670230922, 670230922, 670231019, 670231101, 670231101, 670231123, 670231123, 670231116, 670231205

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.