Product Wiki · Recalls · Health Canada — Medical Devices

Blom-Singer Plug Inserts (2018-03-26) — recall 60862

Health Canada — Medical Devices · Canada · 2018-04-24 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
60862
Date of alert
2018-04-24
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: The Blom-Singer Plug Insert (IN 4069, and IN 4070 lot 0000084674) was packaged and shipped with the incorrect IFU. The devices contained IFU part no. 37-582-01 rev. F (IFU for both valved insert and plug insert with a CE Mark with no Dekra Number, 0344) when they should have had the rev. G IFU (IFU only for plug insert with Ce Mark and Dekra Number, 0344).
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/blom-singer-plug-inserts-2018-

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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