Medical device alert and recall – potential breach in sterile barrier packaging of some products manufactured by ConvaTec Limited

Medical device alert and recall – potential breach in sterile barrier packaging of some products manufactured by ConvaTec Limited

November 14, 2018

ConvaTec has voluntarily initiated a recall of specific product codes of Suction Catheters, Gastroenteral Tubes, Intermittent Urology Catheters and sterile Urine Drainage Bags due to the potential breach in sterile barrier packaging. Only the identified product codes and affected lots within this notice may have a potential breach in the sterile barrier packaging.

Action

  • Refer to the manufacturer’s Field Safety Notice FSN for a list of affected product codes and affected lots.
  • Stop using and quarantine affected devices as directed in the manufacturer’s FSN.
  • Complete the ‘Recall Response Form for END USERS’ in the FSN and return to convatecproductrecall@stericycle.com to arrange return of affected device(s).
  • Report any incidents or complaints involving this product to unomedical-uk.customerservice@convatec.com.

 

Date issued: 14th November 2018

MDA number: MDA/2018/034

Affected products: Full list

Manufacturer contacts

ConvaTec Limited Tel: 01244 832206

Recall centre:  convatecproductrecall@stericycle.com

Email: unomedical-uk.customerservice@convatec.com

 

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



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