Recall Z-2152-2012 ยท CBK Ventilator, Continuous, Facility Use
Impact Instrumentation, Inc.
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.
| Date | Aug 7, 2012 (initiated Mar 19, 2012) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Process control |
| Action | Impact Instrumentation Inc. notified their sole customer via email on 3/15/12 and then emailed an "Urgent Device Product Recall" letter and tracking form dated 3/19/2012. The letter described the reason for the recall and provided recommended actions and the contact number for Customer Service. |
| Quantity | Ten Units |
| Distribution | US Distribution to the state of Illinois. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K103318 | UNI-VENT 731 SERIES MODEL EMV+ PORTABLE CRITICAL CARE VENTILATOR Impact Instrumentation, Inc., Apr 7, 2011 |