Device product
NAMIC Convenience Kit, UPN H749601314811, REF/Catalog No. 60131481, 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-1170-2015
Product summary
- Event
- Event 70322
- Status
- Terminated
- Classification
- Class II
- Quantity
- 411 units
- Official record key
device-enforcement:Z-1170-2015
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 4245021, 4260368, 4268542, 4279333, 4309640, 4344841, 4380268, 4387481, 4390493, 4413788, 4436076, 4436659, 4447611, 4474955, 4491914, 4503486, 4505497, 4534914, 4549037, 4573406, 4576438, 4603643, 4708214, 4714177, 4716348, 4726245, 4729318, 4734982, 4750219, 4750566, 4760725, 4766447, 4779497, 4780532, 4790816, 4802163, 4811301, 4819730, 4822657.
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.