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Recall Observatory FDA recall evidence

Device product

Rigid Suction Canister 3000 CC and 2000 CC.

Z-0352-2017

August 10, 2016

Class II

Product summary

Firm
Medline Industries Inc
Event
Event 75128
Status
Terminated
Classification
Class II
Quantity
7,680 units
Official record key
device-enforcement:Z-0352-2017

Official wording

Reason: Risk of implosion when the Rigid Suction Canister is subjected to excessive negative pressure during use.

Code information: RIGID CANISTER 2000 cc and 3000 cc with product code OR220 and OR230. Affected Lot Numbers 9961601xxxx through 9961604xxxx

Distribution pattern: US Distribution to the following states: CA , CO , FL , GA, GA , IL , MA, MA , MD , MI, MO , NC , NE , NJ , NY, NY , OH, OK , PA, TX and WA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Risk of implosion when the Rigid Suction Canister is subjected to excessive negative pressure during use.