Product Wiki · Recalls · U.S. FDA — Device Enforcement

NAMIC Convenience Kit, UPN H749602001451, REF/Catalog No — recall Z-1187-2015

U.S. FDA — Device Enforcement · United States · 2015-01-09 · Class II

As described by U.S. FDA — Device Enforcement: NAMIC Convenience Kit, UPN H749602001451, REF/Catalog No. 60200145, 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.

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1187-2015
Date of alert
2015-01-09
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Navilyst Medical, Inc
Product category
device
Product type
Devices
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
Worldwide Distribution - US Nationwide and the countries of: Canada, and Guam.
Reported risk: 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.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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