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

Model 731 EMV+ Uni-Vent, Impact Instrumentation Inc., 27 Fairfield… — recall Z-2152-2012

U.S. FDA — Device Enforcement · United States · 2012-03-19 · Class III

As described by U.S. FDA — Device Enforcement: Model 731 EMV+ Uni-Vent, Impact Instrumentation Inc., 27 Fairfield Place, West Caldwell NJ 07006. Indicated for use in the management of acute or chronic respiratory failure or during resuscitation by providing continuous positive -pressure ventilation.

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2152-2012
Date of alert
2012-03-19
Country / jurisdiction
United States
Risk level
Class III
Risk type
recall
Brand
Impact Instrumentation, 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
US Distribution to the state of Illinois.
Reported risk: Ten units of Model EMV+ Devices were shipped out in error before the verification and validation was completed for a new integrated circuit (IC) on the CPU PCB.
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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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.