Device product
NAMIC Convenience Kit, LEFT HEART, POTENTIAL REVISION TO 600604412, UPN H965PK0604436S1, REF/Catalog No. PK0604436S, 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-1205-2015
Product summary
- Event
- Event 70322
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3 units
- Official record key
device-enforcement:Z-1205-2015
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: Lot 4683419
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.