Health product recall

HEMASHIELD PLATINUM Woven Double Velour Single Branch Graft & HEMASHIELD GOLD Knitted Microvel Double Velour Vascular Graft Straight (2020-03-24)

Starting date:
March 24, 2020
Posting date:
April 17, 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-72811

Last updated: 2020-04-17

Affected Products

  1. HEMASHIELD PLATINUM Woven Double Velour Single Branch Graft
  2. HEMASHIELD GOLD Knitted Microvel Double Velour Vascular Graft Straight

    Reason

    There have been five complaints reporting intra-operative bleeding at the seam line of the branches of HEMASHIELD grafts. This issue is limited to specific lot numbers and serial numbers.

    Affected products

    A. HEMASHIELD PLATINUM Woven Double Velour Single Branch Graft

    Lot or serial number

    1123964128

    Model or catalog number

    M00202175830P0

    Companies
    Manufacturer
    INTERVASCULAR, S.A.
    Z.I. ATHELIA 1
    LA CIOTAT
    13705
    FRANCE

    B. HEMASHIELD GOLD Knitted Microvel Double Velour Vascular Graft Straight

    Lot or serial number

    1123964128
    1179647423
    1191566488

    Model or catalog number

    M002020955880

    Companies
    Manufacturer
    INTERVASCULAR, S.A.
    Z.I. ATHELIA 1
    LA CIOTAT
    13705
    FRANCE

    Date modified: