Disposable Semiautomatic/Automatic Biopsy Gun (2021-03-16)

Starting date:

March 16, 2021

Posting date:

March 23, 2021

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

Healthcare Professionals, General Public, Hospitals

Identification number:

RA-75189

Last updated:
2021-07-06

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  Reason
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  Affected products

Affected Products 

1. Disposable Semiautomatic Biopsy Gun SBG-2010
2. Disposable Automatic Biopsy Gun ABG-2020

Reason

Moller Medical was informed that a third-party provider of sterilization services has allegedly intentionally falsified sterilization process records in connection with the processing of Moller Medical products. Moller Medical has immediately carried out an investigation and determined that the sterility of the products cannot be guaranteed. For this reason, the product are temporarily blocked for use on patients.

Affected products