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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = BTL
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