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NAMIC Convenience kit (2015-01-09)
- Starting date:
- January 9, 2015
- Posting date:
- March 6, 2015
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-43793
Recalled products
- NAMIC Convenience kit
Reason
Navilyst medical has determined that the labelled expiration dating of the affected product is not fully supported by shelf life verification testing, which may result in a sterility breach. Use of a fluid management convenience kit, where sterility has been breached, may result in an increased risk of infection.
Affected products
A. NAMIC Convenience kit
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- H965607011741
Companies
- Manufacturer
-
NAVILYST MEDICAL, INC.
26 FOREST STREET
MARLBOROUGH
01752
Massachusetts
UNITED STATES