FDAFDA · Food and drugs·Recall number Z-2152-2012
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.
Published August 15, 2012 · Recall initiated: March 19, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Impact Instrumentation, Inc.
- Distributor
- US Distribution to the state of Illinois.
- Lot
- Serial numbers: VCDB120315, VCDB120316, VCDB120299, VCDB120300, VCDB120313, VCDB120307, VCDB120312, VCDB120303, VCDB120310, VCDB120297.
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
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