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Recall Observatory FDA recall evidence

Device product

Cardinal Health MEDI-VAC CRD Suction Canister Liner, 1000 mL Suction Canister Liner Kit with 5 mm 1.8 m Tube, REF 65651-516

Z-0755-2024

December 21, 2023

Class II

Product summary

Firm
Cardinal Health 200, LLC
Event
Event 93628
Status
Ongoing
Classification
Class II
Quantity
203244 units
Official record key
device-enforcement:Z-0755-2024

Official wording

Reason: The above-listed lots of Cardinal Health Medi-Vac CRD" Suction Canister Liners 1L may experience loss of suction on low or low intermittent suction settings, due to a misalignment of the liner with the outer hard canister.

Code information: 50630140152633 (case), Lot Numbers: J308-606, J308-624, J308-628 J308-642, J308-643, J309-608, J309-610, J309-622, J309-626, J309-633, J309-645, J310-602, J310-617, J310-645

Distribution pattern: US, Canada, Australia and New Zealand

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The above-listed lots of Cardinal Health Medi-Vac CRD" Suction Canister Liners 1L may experience loss of suction on low or low intermittent suction settings, due to a misalignment of the liner with the outer hard canister.