Device product
NAMIC Convenience Kit, RADIOLOGY KIT, UPN H749600617521, REF/Catalog No. 60061752, STERILE, Rx ONLY ---For single use only. --- Device Listing Number D136683. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.
Z-1161-2015
Product summary
- Event
- Event 70322
- Status
- Terminated
- Classification
- Class II
- Quantity
- 30 units
- Official record key
device-enforcement:Z-1161-2015
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 4264475, 4296977, 4344401, 4413661, 4648657, 4673931, 4697105, 4701908, 4723134, 4750810, 4788731.
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.