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STERILE SALINE SOLUTION 0.45% (2015-07-07)
- Starting date:
- July 7, 2015
- Posting date:
- August 11, 2015
- 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-54580
Affected Products
A. STERILE SALINE SOLUTION 0.45%
Reason
A potential carton labeling discrepancy has been identified in association with 0.45% saline solution bottles. The lot number and expiration date indicated on the Carefusion label applied to a shipping carton does not match the lot number and expiration date of the affixed Biomerieux barcode label. The saline solution 0.45% is used in conjunction with the Vitek 2 System for organism identification and/or antimicrobial susceptibility testing.
Affected products
A. STERILE SALINE SOLUTION 0.45%
Lot or serial number
- ZI-0713021
- ZI-0914014
Model or catalog number
- V1211
Companies
- Manufacturer
-
Biomerieux Inc.
595 Anglum Road
Hazelwood
Missouri
UNITED STATES