Medical device alert and recall – Convex two-piece skin barriers (Natura/Surfit/Combihesive Wafers)

Medical device alert and recall – Convex two-piece skin barriers (Natura/Surfit/Combihesive Wafers)

January 16, 2020

Date issued: 16th January 2020

MDA number: MDA/2020/002

ConvaTec has voluntarily initiated a Field Safety Corrective Action in the form of a Customer Notification for specific product codes of Convex Two-Piece Skin Barriers, due to receiving complaints associated with the use of Convex Two-Piece Skin Barriers where the starter hole (stoma hole) is off-centre on products manufactured from February 2017 to September 2018.

Specific products are affected and these can be identified by Product Code and Lot number in the alert here.

Action

  • Identify if you have any devices from the affected lots listed in the manufacturer’s FSN.
  • Contact ConvaTec to arrange return of affected devices and replacements, free of charge.
  • Share this information with all those who may also have affected product, including patients.
  • Complete the ‘End User Response Form’ in the FSN even if you don’t have affected devices left in stock, and return it to tracey.fairclough@amcaregroup.co.uk
  • Report suspected or actual adverse events involving these devices through your local incident reporting system and/or your national incident reporting authority as appropriate: England, Scotland, Northern Ireland, Wales. You should also report directly to manufacturers if your local or national systems do not.

Deadlines for actions 

  • Actions underway: 30th January 2020
  • Actions complete: 13 February 2020

Manufacturer contacts

The manufacturer of the device is Convatec.

Distributors, retailers and wholesalers should contact: Stericycle

Phone: 0800 069 8202

Email: Convatec2p@stericycle.com

Patients should contact: Tracey Fairclough

Phone: 07442 188 256

Email: tracey.fairclough@amcaregroup.co.uk

 

To view the alert please visit the GOV.UK website.

 



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