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U.S. Department of Health and Human Services

Class 3 Device Recall Model 324JL OnBoard Suction System

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  Class 3 Device Recall Model 324JL OnBoard Suction System see related information
Date Initiated by Firm March 30, 2012
Date Posted September 20, 2012
Recall Status1 Terminated 3 on July 21, 2015
Recall Number Z-2430-2012
Recall Event ID 62736
510(K)Number K820331  
Product Classification Apparatus, suction, ward use, portable, ac-powered - Product Code JCX
Product Model 324JL On-Board Suction System
Intended use: On-board suction system for Ambulance manufacturers.
Code Information Model 324JL S/N 120142 and S/N 120144
Recalling Firm/
Manufacturer		 Impact Instrumentation, Inc.
23 Fairfield Pl
West Caldwell NJ 07006-6206
For Additional Information Contact Mr. Alan Giordiano
973-882-1212
Manufacturer Reason
for Recall		 A shipment mix-up took place.
FDA Determined
Cause 2		 Process control
Action The firm, Impact Instrumentation Inc., contacted their customers via phone and email notification on April 9, 2012. Customers were provided the correct packing slip and asked to acknowledge the correction. If you have any questions, contact the Regulatory Affairs Manager at 973-882-1212 or email: aglordano@impactii.com.
Quantity in Commerce 2 devices
Distribution Nationwide distribution: USA including states of: FL and OH.
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 = JCX and Original Applicant = IMPACT INSTRUMENTATION, INC.
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