Events

Recall of VICRYL RAPIDE (POLYGLACTIN 910) SUTURE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    28797
  • Event Risk Class
    II
  • Event Initiated Date
    2010-04-27
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Packaging defect - this recall is an expansion of a recall initiated in august 2008 (recall number 43403). there is a potential that the defect could compromise the integrity of the primary seal which could lead to premature suture degradation and/or impair the sterile barrier of the product.

Device

VICRYL RAPIDE (POLYGLACTIN 910) SUTURE
  • Model / Serial
    Model Catalog: VR496 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: VR494 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: VR493 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: VR490 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: VR945 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: VR497 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: VR931 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: VR845 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: VR844 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: VR835 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: VR834 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: VR932 (Lot serial: >10 NUMBERS CONTACT MFR)
  • Product Description
    VICRYL RAPIDE (POLYGLACTIN 910) SUTURE
  • Manufacturer
    JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.

Manufacturer

JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.