Viaflex container with connector (2013-11-26)

Starting date:

November 26, 2013

Posting date:

March 20, 2014

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-38431

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  Reason
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  Affected products

Recalled Products

Viaflex container with connector

Reason

Safety alert communication issued for additional instruction, in some cases not included on labeling for Viaflex container with connector: do not use flexible solution container if the administration port protector is not in place prior to use. Baxter requested customers to not use flexible solution containers if the administration protector is not in place. The port protector serves as a sterility barrier and if port protector missing sterility of administration port may be compromised, potentially placing patients at risk of blood stream infection due to microbial contamination introduced to the fluid path. No associated deaths or serious injury related to this issue.

Affected products