Device product
NAMIC Convenience Kit, UPN H965601206511, REF/Catalog No. 60120651, 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.
Z-1199-2015
Product summary
- Event
- Event 70322
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3 units
- Official record key
device-enforcement:Z-1199-2015
Official wording
Reason: 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.
Code information: Lots 4720602 and 4725234
Distribution pattern: Worldwide Distribution - US Nationwide and the countries of: Canada, and Guam.
Derived failure modes
-
Unknown
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.