Xcela and BioFlo PICC (2016-11-28)

Starting date:

November 28, 2016

Posting date:

December 13, 2016

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-61404

• Reason
• Affected products

Affected Products

1. Xcela Picc with PASV Valve, MST Kit
2. Xcela Picc with PASV Valve, IR Kit
3. BioFlo Picc MST-70 Kit

Reason

Navilyst Medical Inc. (an angiodynamics company), is conducting a medical device recall to the end user level based on information received from Greatbatch Medical, the manufacturer of the ViaPeel Peelable IntroducerViaPeel. Greatbatch medical has determined that the products listed in their November 11, 2016 recall notification have the potential for the handles to detach from the sheath during use. Navilyst Medical has confirmed that the affected sheaths, Greatbatch model number 10890-006, have been included in packaged Xcela and BioFlo PICC Kits.

Affected products