Recall Z-0870-2012
Impact Instrumentation, Inc. · initiated November 4, 2011
Product
Model 73X Uni-Vent Product Usage: Intended for use at mass casualty incidents.
Codes / lots: K051476
Reason for recall
A piece of internal tubing in the 73X portable ventilator is of incorrect specifications for the device.
FDA-determined cause: Component design/selection
Action taken
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
Details
- Recall number
- Z-0870-2012
- Initiated
- November 4, 2011
- Terminated
- May 23, 2013
- Product code
- BTL – Ventilator, Emergency, Powered (Resuscitator)
- Quantity
- 57 units
- Distribution
- Worldwide Distribution - USA (nationwide)
- Recalling firm
- Impact Instrumentation, Inc., West Caldwell, NJ