Device product
NAMIC Convenience Kit, LEFT HEART KIT, UPN H7496007057101, REF/Catalog No. 600705710, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.
Z-1163-2015
Product summary
- Event
- Event 70322
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5 units
- Official record key
device-enforcement:Z-1163-2015
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 4393719, 4617238, 4717511.
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.