Sterile 0.9% Sodium Chloride and Sterile Water For Irrigation (2018-04-02)

Starting date:

April 2, 2018

Posting date:

May 18, 2018

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-66782

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  Reason
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  Affected products

Affected products

Sterile 0.9% Sodium Chloride and Sterile Water For Irrigation

Reason

Vyaire Medical (a company comprised of the respiratory solution businesses previously a part of CareFusion/BD) has initiated a voluntary recall of the airlife part numbers AL4100, Sterile Water and Al4109, 0.9% Normal Saline Solutions.  Vyaire Medical has discovered that the items contain an error in double labeling; the back product label was incorrectly placed over top of the front product label.  The error in labelling results in the obscuring of the part number and product information.  The product expiry and lot number information remain visible in the presence of the error in labeling.

Affected products