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

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  Reason
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  Affected products

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