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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 Systemsee related information
Date Initiated by FirmApril 26, 2022
Date PostedMay 30, 2022
Recall Status1 Terminated 3 on August 20, 2024
Recall NumberZ-1138-2022
Recall Event ID 90061
510(K)NumberK200988 
Product Classification Device, positive pressure breathing, intermittent - Product Code NHJ
ProductIn-Line ventilator adaptor
Code Information M08473 OPTIMUS OLE AC PAT.CIRCUIT KIT; UDI-DI: 00887761981492. Manufacturing dates February 28, 2020 to present.
Recalling Firm/
Manufacturer		 Baxter Healthcare Corporation
1 Baxter Pkwy
Deerfield IL 60015-4625
For Additional Information ContactCenter 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		Device Design
ActionThe 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 Commerce259 units
DistributionUS 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 CycleTPLC 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) Database510(K)s with Product Code = NHJ
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