Health product recall

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

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

  1. Polysorb Braided Synthetic Absorbable Surgical Suture

Lot or serial number
  • A9H0847FY
  • A9H0927Y
  • D7H0876X
  • D7H1126X
Model or catalog number
  • CL461
  • CL915
  • L1742K
  • SL5679
Companies
Manufacturer

Covidien LLC

15 Hampshire Street

Mansfield

02048

Massachusetts

UNITED STATES


B. Biosyn Glycomer Monofilament Synthetic Absorbable Suture

Lot or serial number

D7H0404X

Model or catalog number

UM201

Companies
Manufacturer

Covidien LLC

15 Hampshire Street

Mansfield

02048

Massachusetts

UNITED STATES