11 GAUGE BONE ACCESS NEEDLE (2015-06-26)

Starting date:

June 26, 2015

Posting date:

July 29, 2015

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-54444

• Reason
• Affected products

Affected Products

A. 11 GAUGE BONE ACCESS NEEDLE 

Reason

Manufacturer received customer report of a potential defect in the forming of the primary package of the blister that may compromise the sterility of the product inside the tray. Manufacturer has evaluated all in-house inventories, and the expected defect rate is extremely small. As a precautionary measure, manufacturer is conducting a voluntary recall to notify customers of the potential of this packaging defect. Manufacturer has not received any reports of patient harm or infection attributed to this issue, however, invasive medical procedures conducted using non-sterile products could result in an infection for the patient.

Affected products