CADD Blue-Striped Administration Set (2018-02-28)

Starting date:

February 28, 2018

Posting date:

March 23, 2018

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-66270

• 
  Reason
• 
  Affected products

Affected products

CADD Blue-Striped Administration Set

Reason

A detailed investigation points to a unique use case, involving a single Canadian customer using non-approved Smiths Medical pouches, with the CADD Blue-Striped Administration Set. Use of non-approved accessories, as indicated in labeling, may adversely affect pump operation. Smiths Medical has decided to proceed with sending communication to notify all Canadian customers who have purchased the CADD Blue-Striped Administration Set. The content of the Field Safety Notice (FSN) provides more information to the customer/user when using the administration set. FSN emphasizes the correct use of the product and how to avoid strain relief which in turn prevents leakage.

Affected products