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
Affected Products
- Disposable Semiautomatic Biopsy Gun SBG-2010
- 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
A. Disposable Semiautomatic Biopsy Gun SBG-2010
Lot or serial number
Lot # 19123128
Lot # 2002427
Lot # 2002524
Lot # 2003786
Model or catalog number
SBG-2010-14-0100
SBG-2010-18-0100
SBG-2010-18-0200
Companies
- Manufacturer
-
MOLLER MEDICAL GMBH
WASSERKUPPENSTRASSE 29-31
FULDA
36043
GERMANY
B. Disposable Automatic Biopsy Gun ABG-2020
Lot or serial number
Lot # 20051240
Model or catalog number
ABG-2020-18-0200
Companies
- Manufacturer
-
MOLLER MEDICAL GMBH
WASSERKUPPENSTRASSE 29-31
FULDA
36043
GERMANY