Health product recall

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

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

Sterile 0.9% Sodium Chloride and Sterile Water For Irrigation

Lot or serial number

AL4100, lot T17M11
AL4109, lot T17K03
AL4109, lot T17K05
AL4109, lot T17M07
AL4109, lot T17M08
AL4109, lot T17M13
AL4109, lot T17M14
AL4109, lot T17M15
AL4109, lot T17N16

Model or catalog number

AL4100
AL4109

Companies
Manufacturer

VYAIRE MEDICAL (FORMERLY TRADING AS CAREFUSION)

22745 Savi Ranch Parkway

Yorba Linda

92887

California

UNITED STATES