Device product
NAMIC Convenience Kit, LEFT/RIGHT HEART KIT, UPN H7496008010201, REF/Catalog No. 600801020, 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-1165-2015
Product summary
- Event
- Event 70322
- Status
- Terminated
- Classification
- Class II
- Quantity
- 105 units
- Official record key
device-enforcement:Z-1165-2015
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 4268419, 4310080, 4344788, 4393891, 4416012, 4462784, 4535382, 4575640, 4608478, 4624082, 4641213, 4666593, 4680409, 4689497, 4696721, 4707605, 4730974, 4742627, 4759572, 4772627, 4782953, 4793007, 4793974, 4824273.
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.