Home / Recalls / Navilyst Medical, Inc / Z-1165-2015

Z-1165-2015 Class II Terminated

Recalled by Navilyst Medical, Inc — Glens Falls, NY

Recall Details

Product Type
Devices
Report Date
March 4, 2015
Initiation Date
January 9, 2015
Termination Date
March 10, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
105 units

Product Description

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.

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.

Distribution Pattern

Worldwide Distribution - US Nationwide and the countries of: Canada, and Guam.

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.

Other recalls by Navilyst Medical, Inc

  • Z-1164-2015 Class II — NAMIC Convenience Kit, 3 VALVE KIT, UPN H749600709971, REF/Catalog No. 60070997, (January 9, 2015)
  • Z-1171-2015 Class II — NAMIC Convenience Kit, UPN H7496013148131, REF/Catalog No. 601314813, STERILE, R (January 9, 2015)
  • Z-1204-2015 Class II — NAMIC Convenience Kit, UPN H965607011741, REF/Catalog No. 60701174, STERILE, Rx (January 9, 2015)
  • Z-1199-2015 Class II — NAMIC Convenience Kit, UPN H965601206511, REF/Catalog No. 60120651, STERILE, Rx (January 9, 2015)
  • Z-1195-2015 Class II — NAMIC Convenience Kit, UPN H965600338021, REF/Catalog No. 60033802, STERILE, Rx (January 9, 2015)
  • Z-1152-2015 Class II — NAMIC Convenience Kit, LEFT HEART KIT, UPN H749600309351, REF/Catalog No. 600309 (January 9, 2015)
  • Z-1189-2015 Class II — NAMIC Convenience Kit, UPN H749602301481, REF/Catalog No. 60230148, STERILE, Rx (January 9, 2015)
  • Z-1194-2015 Class II — NAMIC Convenience Kit, ANGIO DOUBLE SPIKE KIT, UPN H9656003028111, REF/Catalog N (January 9, 2015)
  • Z-1170-2015 Class II — NAMIC Convenience Kit, UPN H749601314811, REF/Catalog No. 60131481, STERILE, Rx (January 9, 2015)
  • Z-1153-2015 Class II — NAMIC Convenience Kit, UPN H749600329421, REF/Catalog No. 60032942, STERILE, Rx (January 9, 2015)