Health product recall

Beacon EUS Access System Preloaded 90? Access Needles (2020-07-08)

Starting date:
July 8, 2020
Posting date:
August 14, 2020
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-73679



Last updated:
2020-08-14

Affected Products

Beacon EUS Access System Preloaded 90? Access Needles

Reason

This voluntary recall is being conducted following three customer reports of the device cannula detaching during a procedure. In one case, the detached cannula was not retrieved during the procedure. Potential risks associated with a detached cannula include delay in treatment, biliary leak, pain and retained device fragments.

Affected products

Beacon EUS Access System Preloaded 90? Access Needles
Lot or serial number

F2510900X

F2512378X

Model or catalog number

DSA-090-01

DSA-135-01

Companies
Manufacturer

Covidien LLC

15 Hampshire Street

Mansfield

02048

Massachusetts

UNITED STATES