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