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Terminated

Model 73X Uni-Vent Product Usage: Intended for use at mass casualty incidents.

FDA Recall Z-0870-2012 · Posted None

Recalling FirmImpact Instrumentation, Inc.
Recall StatusTerminated
Product CodeBTL
Date Initiated2011-11-04
Date Terminated2013-05-23
Product Quantity57 units

Reason for Recall

A piece of internal tubing in the 73X portable ventilator is of incorrect specifications for the device.

Firm 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

Root Cause

Component design/selection

Distribution Pattern

Worldwide Distribution - USA (nationwide)

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K051476UNI-VENT MODEL 73XImpact Instrumentation, Inc. · 2005-10-28

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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