Arrow On Control Systems (2016-11-08)

Starting date:

November 8, 2016

Posting date:

December 5, 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, Hospitals, Healthcare Professionals

Identification number:

RA-61294

• 
  Reason
• 
  Affected products

Affected Products

A. Arrow OnControl System Sterile Procedure Tray

B. Arrow OnControl Bone Marrow Biopsy System Tray

C. Arrow OnControl Bone Lesion Biopsy System Tray

D. OnControl Biopsy System Ported Needle Tray

E. Arrow OnControl Bone Marrow Biopsy System Comprehensive Tray

Reason

Teleflex is recalling this product due to a potential incomplete seal of the outer sterile package. Because of the compromised packaging, the sterility of the inside drape, which is used in preparation for bone marrow aspiration with the OnControl System, cannot be guaranteed.  If sterility of the drape is compromised, there is a potential for infection to occur.

Affected products