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Recall Observatory FDA recall evidence

Device product

LINER, SOFT, SUCTION CANISTER, 1500CC, REF DYNDSCL1500

Z-2694-2024

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-2694-2024

Official wording

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

Code information: UDI/DI 40884389129532 (package), 10884389129531 (unit), Lot Numbers: 670220523, 670220531, 670220613, 670220530, 670220624, 670220613, 670220704, 670220704, 670220624, 670220624, 670220713, 670220713, 670220727, 670220721, 670220804, 670220912, 670220916, 670220901, 670220916, 670220916, 670221013, 670221013, 670221013, 670221013, 670221026, 670221026, 670221103, 670221103, 670221103, 670221103, 670221103, 670221129, 670221207, 670221210, 670221224, 670221210, 670230103, 670230103, 670221210, 670230103, 670221210, 670230208, 670230208, 670230220, 670230220, 670230306, 670230313, 670230327, 670230327, 670230414, 670230422, 670230414, 670230427, 670230510, 670230518, 670230525, 670230925, 670230925, 670230925, 670231006, 670231020, 670231103, 670231103, 670231114, 670231201, 670231201, 670231127

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.