Polysorb Braided Synthetic Absorbable Surgical Suture & Biosyn Glycomer Monofilament Synthetic Absorbable Suture (2019-12-20)

Starting date:

December 20, 2019

Posting date:

January 10, 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-72095

Last updated: 2020-01-10

• 
  Reason
• 
  Affected products

Affected Products

1. Polysorb Braided Synthetic Absorbable Surgical Suture
2. Biosyn Glycomer Monofilament Synthetic Absorbable Suture

Reason

This voluntary recall is being conducted due to the potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots of these absorbable sutures. These conditions may result in premature degradation of the suture material or compromise the product's sterile condition. The use of products with an incomplete seal of the humidity barrier may increase the potential for the suture to break. The use of products with a compromised sterile barrier may result in a potentially increased risk for infection. There have been no reports of patient injury associated with these issues.

Affected products