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U.S. Department of Health and Human Services

Class 3 Device Recall Pneupac paraPac plus 300 ventilator kit

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  Class 3 Device Recall Pneupac paraPac plus 300 ventilator kit see related information
Date Initiated by Firm July 15, 2021
Create Date October 22, 2021
Recall Status1 Terminated 3 on August 11, 2023
Recall Number Z-0163-2022
Recall Event ID 88675
510(K)Number K123957  
Product Classification Ventilator, emergency, powered (resuscitator) - Product Code BTL
Product Pneupac paraPac plus 300 ventilator kit, REF P300NGB
Code Information SN RF70121
Recalling Firm/
Manufacturer		 Smiths Medical ASD Inc.
6000 Nathan Ln N
Minneapolis MN 55442-1690
For Additional Information Contact Dave Halverson
763-383-3310
Manufacturer Reason
for Recall		 Two devices were labeled with the same serial number
FDA Determined
Cause 2		 Process control
Action The firm notified the consignee by email on 07/15/2020 and requested the return of the units.
Quantity in Commerce 2 units
Distribution UK
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 = SMITHS MEDICAL INTERNATIONAL LTD.
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