Events

Recall of MERSILENE NON-ABSORBABLE POLYESTER FIBER 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
    47915
  • Event Risk Class
    II
  • Event Initiated Date
    2016-08-02
  • 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
    Ethicon has initiated a worldwide medical device correction (notification) for unexpired lots of select ethicon mersilene tape (also referred to as mersilene polyester fiber strip or mersilene fiber ligature) products as it was discovered that a group of mersilene tape product codes are being supplied with an incorrect instructions for use (ifu) insert. the product codes subject to this correction are being supplied with a mersilene suture ifu. corrective actions are currently being implemented to include the correct mersilene tape ifu with future shipments of mersilene tape products. this notification serves as an immediate correction to provide customers with the correct mersilene tape ifu.

Device

MERSILENE NON-ABSORBABLE POLYESTER FIBER SUTURE
  • Model / Serial
    Model Catalog: D7164 (Lot serial: All Unexpired Lots); Model Catalog: D8113 (Lot serial: All Unexpired Lots); Model Catalog: D8062 (Lot serial: All Unexpired Lots); Model Catalog: RS20 (Lot serial: All Unexpired Lots); Model Catalog: RS21 (Lot serial: All Unexpired Lots); Model Catalog: RS22 (Lot serial: All Unexpired Lots); Model Catalog: RS23 (Lot serial: All Unexpired Lots)
  • Product Description
    MERSILENE NON-ABSORBABLE POLYESTER FIBER SUTURE;MERSILENE WOVEN TAPE;MERSILENE NON ABSORBABLE POLYESTER FIBER SUTURE
  • Manufacturer
    JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.

Manufacturer

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