ARROW INTERNATIONAL VPS ACCESS KIT WITH TUOHY BORST COMPONENT(2015-08-11)

Starting date:

August 11, 2015

Posting date:

August 24, 2015

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-54792

• Reason
• Affected products

Affected Products

A. ARROW INTERNATIONAL VPS ACCESS KIT WITH TUOHY BORST COMPONENT

Reason

Arrow is recalling certain lots of the products referenced above due to reports clinicians have had difficulty maintaining a secure connection between the male Luer of the Tuohy Borst Adapter of the vascular positioning system stylet to the hub of the catheter. When the connection is not secure, there is a possibility the connection will leak saline. This is most often discovered during initial flushing prior to insertion, in which case, a delay in treatment can occur while the health care provider locates a replacement device. In the unlikely event that the issue is discovered while the device is in use, it could result in an inability to obtain a signal on the VPS console. This would in turn necessitate removal and replacement of the catheter or an x-ray to confirm proper catheter placement.

Affected products