Health product recall

ENDOCUFF VISION (2021-07-12)

Starting date:
July 12, 2021
Posting date:
July 29, 2021
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-76099

Last updated: 2021-07-30

Affected Products 

ENDOCUFF VISION

Reason

Boddingtons Plastics LTD. (Boddingtons), became aware of an irregularity in the packaging process of the subject products which could lead to a packaging seal defect. This product is supplied sterile and a bread of the package's sterile barrier might lead to patient infection. The risk of infection is considered extremely improbably due as the devices are intended for use in the lower gastrointestinal tract. However, Boddingtons is conducting a recall to inform customers and users of this possibility and offer a credit for the return of any products with
this packaging anomaly.

Affected products

ENDOCUFF VISION

Lot or serial number

More than 10 numbers, contact manufacturer. 

Model or catalog number

ARV 110
ARV 120
ARV 130
ARV 140

Companies
Manufacturer
BODDINGTONS PLASTICS LTD
WHEELBARROW PARK ESTATE, PATTENDEN LANE
Tonbridge
TN12 9QJ
UNITED KINGDOM