BD Q-Syte Luer Access Split Septum (2015-02-17)

Starting date:

February 17, 2015

Posting date:

March 20, 2015

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-52603

• Reason
• Affected products

Recalled Products

A) BD Q-Syte Luer Access Split Septum

Reason

May fail to conform to a claim made by the manufacturer or importer relating to its performance and may be hazardous to health: the silicone column of the septum of the BD Q-Syte luer access split septum device is torn, resulting in leakage of blood or infusate from the side holes, or the remote potential for air bubbles to enter into the bloodstream if a negative pressure/vacuum situation is created. Date the event was first identified: December 24, 2014. Description of how the event was identified: an increase in the number of complaints for this product was identified internally. Note that there have been no complaints for air in the line related to the use of the device with a peripheral IV or a CVC line. There have also been no complaints for this product from Canadian customers.

Affected products