BD Vacutainer Plus 2.7 mL Citrate Blood Collection Tube

Starting date:

November 19, 2012

Posting date:

January 7, 2013

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public (GP), Healthcare Professionals, Hospitals

Identification number:

RA-16631

• 
  Reason
• 
  Affected products

Recalled Products

A. BD Vacutainer Plus 2.7 mL Citrate Blood Collection Tube

Reason

There is evidence that in a portion of the affected lot there is a cross-contamination with lithium heparin, in a concentration not exceeding 1.2 iu per milliliter in plasma obtained from properly filled tubes (note: this value was obtained from healthy subjects using a limited number of tubes from the affected lot). The internal investigation completed by bd indicates that this contaminant can adversely affect coagulation results. Erroneous results may lead to inappropriate decisions regarding patient care. For a full listing of assays that may be adversely affected by the lithium heparin contaminant, please contact the manufacturer.

Affected products