RegWardenFDA facility compliance records
Recall

Class II — Atrium Medical Corporation

Recalling firmATRIUM MEDICAL CORPORATION
Registered facilityAtrium Medical Corporation (the firm's only registered facility)
ClassificationClass II
StatusTerminated
ReasonChest drains have a missing o-ring
ProductOcean Water Seal Chest Drain, SINGLE W/AC P/N: 2002-100
Quantity130 cases
DistributionNationwide Canada, Germany
Initiated2015-05-07
Classified2015-06-29
Terminated2016-04-26
Recall numberZ-1936-2015
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Atrium Medical Corporation (Z-1936-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/71023/

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