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