FDAFDA · Food and drugs·Recall number Z-1184-2015
NAMIC Convenience Kit, UPN H749601904231, REF/Catalog No. 60190423, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.
Published March 4, 2015 · Recall initiated: January 9, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Navilyst Medical, Inc
- Distributor
- Worldwide Distribution - US Nationwide and the countries of: Canada, and Guam.
- Lot
- Lot 4802267
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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