Reported Aug 15, 2012 · Terminated
Model 731 EMV+ Uni-Vent, Impact Instrumentation Inc., 27 Fairfield Place, West Caldwell NJ 07006. Indicated for use in…
Impact Instrumentation, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Impact Instrumentation, Inc. · 23 Fairfield Pl · West Caldwell, NJ · 07006-6206
Is this the product you have?
- 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.
- Lot codes and dates
- Serial numbers
VCDB120315VCDB120316VCDB120299VCDB120300VCDB120313VCDB120307VCDB120312VCDB120303VCDB120310VCDB120297
- Serial numbers
- Amount recalled
- Ten Units
Where it was sold
Why it was recalled
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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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