Recall Z-1199-2015— Navilyst Medical, Inc
Class II · Terminated
Class II FDA medical device recall by Navilyst Medical, Inc, initiated 2015-01-09, terminated 2017-03-10. FDA's recall record names no specific 510(k) clearance for this event. Product: NAMIC Convenience Kit, UPN H965601206511, REF/Catalog No. 60120651, 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.. 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..
- Recalling firm
- Navilyst Medical, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-01-09
- Terminated
- 2017-03-10
- Firm location
- Glens Falls, NY, United States
Product description
NAMIC Convenience Kit, UPN H965601206511, REF/Catalog No. 60120651, 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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.