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U.S. Department of Health and Human Services

Class 2 Device Recall UNIVENT MODEL 73X

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  Class 2 Device Recall UNIVENT MODEL 73X see related information
Date Initiated by Firm November 04, 2011
Create Date June 26, 2015
Recall Status1 Terminated 3 on May 23, 2013
Recall Number Z-0870-2012
Recall Event ID 60786
510(K)Number K051476  
Product Classification Ventilator, emergency, powered (resuscitator) - Product Code BTL
Product Model 73X Uni-Vent

Product Usage: Intended for use at mass casualty incidents.
Code Information K051476 
Recalling Firm/
Manufacturer		 Impact Instrumentation, Inc.
23 Fairfield Pl
West Caldwell NJ 07006-6206
For Additional Information Contact Mr. Alan Giordano
973-882-1212
Manufacturer Reason
for Recall		 A piece of internal tubing in the 73X portable ventilator is of incorrect specifications for the device.
FDA Determined
Cause 2		 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 in Commerce 57 units
Distribution Worldwide Distribution - USA (nationwide)
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = BTL and Original Applicant = IMPACT INSTRUMENTATION, INC.
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