Turnpike LP Catheter (2018-06-28)

Starting date:

June 28, 2018

Posting date:

July 13, 2018

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-67232

• 
  Reason
• 
  Affected products

Affected products

Turnpike LP Catheter

Reason

IFU in the affected lot has an incorrect dimension within the product specification table. The distal shaft outer diameter is listed as 0.86mm/0.034 inches. The actual dimension is 0.74mm/0.029 inches. The issue was caused by translation service vendor; the change was not prompted through a red-lined copy. Box and pouch label are accurate.

Affected products