Class 3 Device Recall Pneupac paraPac plus 300 ventilator kit

• Date Initiated by Firm: July 15, 2021
• Create Date: October 22, 2021
• Recall Status: Terminated 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: 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