Recall Z-0870-2012 ยท BTL Ventilator, Emergency, Powered (Resuscitator)
Impact Instrumentation, Inc.
Model 73X Uni-Vent Product Usage: Intended for use at mass casualty incidents.
| Date | Nov 4, 2011 |
| Status | Terminated |
| Reason | A piece of internal tubing in the 73X portable ventilator is of incorrect specifications for the device. |
| Root cause | Component design/selection |
| Action | Impact Instrumentation Inc. sent an URGENT Device Product Recall letter dated November 3, 2011 to all affected consignees. The letter identified the product, problem, instructions for product returns, and actions to be taken. The letter states that Impact will arrange for expedited return, at no charge to the customers of the affected units. The notice instructs customers to complete and return the Recall Tracking Form. If you need additional information, please call Impact Customer Service at (800) 969-0750 |
| Quantity | 57 units |
| Distribution | Worldwide Distribution - USA (nationwide) |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051476 | UNI-VENT MODEL 73X Impact Instrumentation, Inc., Oct 28, 2005 |