8f Xcela Plus Implantable Ports & 8f Bioflo Plus Implantable Ports (2019-09-18)

Starting date:

September 18, 2019

Posting date:

January 10, 2020

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-72097

Last updated: 2020-01-10

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  Reason
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  Affected products

Affected Products

1. 8f Xcela Plus Implantable Ports
2. 8f Bioflo Plus Implantable Ports

Reason

AngioDynamics, Inc. (dba Navilyst Medical), the manufacturer of the BioFlo and Xcela Plus implantable ports, is conducting a medical device recall to the end user level upon awareness that snap lock connectors provided within 8F BioFlo and Xcela Plus implantable port kits may not meet dimensional specifications and will not allow for a secure connection between the port chamber and the catheter. Specifically, the catheter cannot be inserted into the snap lock connector prior to connection to the port chamber, resulting in a delay to the implantation procedure.

Affected products