PROXIMATE HCS Hemorrhoidal Circular Stapler and PROXIMATE PPH Procedure for Prolapse and Hemorrhoids Set (2018-12-11)

Starting date:

December 11, 2018

Posting date:

January 9, 2019

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-68644

• 
  Reason
• 
  Affected products

Affected products

1. PROXIMATE HCS Hemorrhoidal Circular Stapler
2. PROXIMATE PPH Procedure for Prolapse and Hemorrhoids Set

Reason

Ethicon has initiated a voluntary recall (removal) of specific lots of PROXIMATE Hemorrhoidal Circular Stapler (pph01 and pph03). Ethicon has confirmed that some devices contained in these lots may have been assembled without a washer. For that reason, they are issuing this voluntary recall for the affected product lots.

Affected products