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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