Carefusion Biopsy Needle (2017-02-22)

Starting date:

February 22, 2017

Posting date:

March 16, 2017

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-62650

• Reason
• Affected products

Affected Products

A. Manometer Tray
B. Thoracentesis/Paracentesis Kit
C. Jamshidi Biopsy Needle
D. Jamshidi Bone Marrow Biopsy/Aspiration Needle
E. Bone Marrow Aspiration/Intraosseous Needle

Reason

Carefusion, a subsidiary of BD, has identified a potential risk associated with the packaging integrity- open seal. If this failure were to occur while in use in a procedure it has the potential to result in an inflammatory / infectious response locally and/or systemically.

Affected products