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U.S. Department of Health and Human Services

Class 2 Device Recall Hemolung Respiratory Assist System

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  Class 2 Device Recall Hemolung Respiratory Assist System see related information
Date Initiated by Firm December 18, 2020
Create Date January 29, 2021
Recall Status1 Terminated 3 on May 17, 2021
Recall Number Z-0938-2021
Recall Event ID 87048
Product Classification Extracorporeal system for carbon dioxide removal - Product Code QLN
Product ALung Technologies Hemolung Respiratory Assist System (RAS) with CME BodyGuard 323 Infusion Pump(EUA) - Product Usage: an off-the-shelf infusion pump and administration set to provide a 30 mL/hr continuous saline flush to the integrated blood pump bearing.
Code Information Serial Numbers: A11530 A11531 A11532 A11533 A11534 A11535 A11536 A11537 A11538 A11539 A11541 A11543 A11544 A11545 A11546 A11548 A11552 A11553 A11554 A11555 A11556 A11557 A11561 A11562 A11563 A11565 A11566 A11567 A11568 A11569 A11570 A11571 A11572 A11573 A11575 A11576 A11577 A11578 A11579 A11580 A11581 A11582 A11583 A11584 A11585 A11586 A11587 A11590 A11591 A11592 A16164 A16794 A16795 A16796 A16797 A16798 A16799 A16800 A16801 A16802 A16803 A16804 A16805 A16806 A16807 A16808 A16809 A16810 A16811 A16812 A16813 A16814 A16815 A16816 A16817 A16818 A16819 A16820 A16821 A16822 A16823 A16824 A16825 A16826 A16827 A34951 A34952 A34953 A34954 A34955 A34957 A34958 A34960 A34961 A34962 A34963 A34964 A34965 A34967 A34969 A34970 
Recalling Firm/
Manufacturer		 Alung Technologies Inc
2500 Jane St Ste 1
Pittsburgh PA 15203-2216
For Additional Information Contact Tracey Dill
412-697-3370 Ext. 231
Manufacturer Reason
for Recall		 CME America BodyGuard 323 Infusion Pumps (recalled by manufacturer) is a component to the Hemolung for EUA, and the infusion pump may have a delivery inaccuracy
FDA Determined
Cause 2		 Nonconforming Material/Component
Action ALung issued email notification "Recalled CME BodyGuard 323 Infusion Pump to Sapphire Pump Exchange" on 12/18/20 . Letter notifies users of the CME/Sapphire Infusion Pump exchange. Provided with this email are the instructions that will come with the infusion pump package. We wanted to give you a preview of what is coming prior to the packages arriving. Once received, we ask that you promptly remove the current CME pump, package and ship back to ALung. These are needed to be returned to the manufacturer by the end of the year. Reminder you may need to contact biomed for the electrical safety testing of the new Sapphire pump! Please follow your internal protocols.
Quantity in Commerce 101 units
Distribution US Nationwide distribution.
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.
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