Blom-Singer Plug Inserts (2018-03-26)

Starting date:

March 26, 2018

Posting date:

April 24, 2018

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-66572

• Reason
• Affected products

Affected products

Blom-Singer Plug Inserts

Reason

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).

Affected products