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U.S. Department of Health and Human Services

Class 1 Device Recall Volara System

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  Class 1 Device Recall Volara System see related information
Date Initiated by Firm April 26, 2022
Create Date May 30, 2022
Recall Status1 Open3, Classified
Recall Number Z-1139-2022
Recall Event ID 90061
510(K)Number K200988  
Product Classification Device, positive pressure breathing, intermittent - Product Code NHJ
Product In-Line ventilator adaptor
Code Information M07937 MODULE, OPTIMUS HANDSET 2; UDI-DI: 00887761984622. Manufacturing dates October 17, 2019 to present.
Recalling Firm/
Manufacturer		 Baxter Healthcare Corporation
1 Baxter Pkwy
Deerfield IL 60015-4625
For Additional Information Contact Center for One Baxter
800-422-9837
Manufacturer Reason
for Recall		 There is a potential of reduced oxygenation or pneumothorax/barotrauma to occur when the Volara system is used with in-line ventilator in home care environment.
FDA Determined
Cause 2		 Under Investigation by firm
Action The recall notification was sent to consignees on 04/26/2022 via FedEx. The customer was instructed to sign acknowledgement form to confirm receipt and return to Hillrom using pre-paid envelope.
Quantity in Commerce 9 units
Distribution US Nationwide distribution in the states of TX, FL, VA, KY, CA, AZ, WI, IL, NC, OH, MI, MS, MO, MN, AL, TN, SD, OK, NV, NJ, IN, CO, GA, WA, PA, IA, NE, NM, SC, ND, KS, WV, OR.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = NHJ and Original Applicant = Hill-Rom Services Pte Ltd
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