Smiths Emdical Blood Sampling Kits (2013-11-18)

Starting date:

November 18, 2013

Posting date:

December 17, 2013

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-37217

• Reason
• Affected products

Recalled products

1. Pro-Vent Plus Arterial Blood Sampling Kit
2. Dry Line Draw Plus Arterial Blood Sampling Kit
3. Umbilical Line Draw Plus Arterial Blood Sampling Kit

Reason

Smith Medical has identified an issue with ABL syringes when used with Radiometer brand blood gas analyzers. In August 2013, Smiths Medical began receiving a small number of complaints regarding use of the ABL syringes with Radiometer blood analyzers. The plunger tip in the ABL syringe does not remain stationary when the probe of the analyzer extends into the syringe. This allows air to leak into the sample at the luer, stopping the blood from entering the analyzer probe and preventing the analysis of blood. This can result in difficulties aspirating the sample or the plunger may get pushed out of the syringe.  Smiths Medical has received no reports of injury associated with this issue.

Affected products