Baxter Healthcare Corporation: Hillrom VOLARA System P.CIRCUIT KIT (Single Patient Use Circuit), Model/Catalog Number REF M08085; Oscillation Lung Expansion Therapy, positive pressure breathing device

Recall number

Z-2548-2026

Recalling firm

Baxter Healthcare Corporation

Product

Hillrom VOLARA System P.CIRCUIT KIT (Single Patient Use Circuit), Model/Catalog Number REF M08085; Oscillation Lung Expansion Therapy, positive pressure breathing device

Status

Open, Classified

Initiated

2026-05-21

Posted

2026-07-01

Terminated

not on file

Reason

There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the patient and ineffective nebulization, which may affect the delivery of the prescribed treatment. The issue has been associated with improper locking of the nebulizer cup after adding medication during user setup.

Root cause

Nonconforming Material/Component

Action

Baxter issued an URGENT MEDICAL DEVICE CORRECITON notice to its consignees on 5/21/2026 via USPS first class mail. The notice explained the issue, hazard involved, and requested the following: "Actions to be Taken by Customers 1. Before each use, carefully inspect the nebulizer cup for damage and ensure it is fully and securely locked during assembly, following the enclosed instructions. If leakage is observed during therapy, discontinue the use of that nebulizer and replace the patient circuit. 2. Nebulizer cups with patient circuits are routinely replaced as part of normal therapy usage. Additional patient circuits can be provided through standard distribution. 3. If you received this communication directly from Baxter, please acknowledge receipt of this notification by responding on our customer portal at https://BaxterFieldActionCustomerPortal.onprocess.com, even if you do not have any remaining inventory. Log in to the portal using the account number listed in the enclosed reply instruction sheet. Acknowledging receipt of this notification will prevent you from receiving repeat notices. If you do not complete the acknowledgement, you will receive a phone call from Accenture LLP on behalf of Baxter to confirm your receipt of this notification. 4. If you purchased this product from a distributor or wholesaler, please note that responding on the Baxter customer portal is not applicable. If a response is requested by your distributor or wholesaler, please respond to the supplier according to their instructions. 5. If you distributed this product to other facilities or departments within your institution, please forward a copy of this communication to them. 6. If you are a dealer, wholesaler, distributor/reseller, or original equipment manufacturer (OEM) that distributed any affected product to other facilities, please notify your customers of this urgent medical device correction in accordance with your customary procedures and check the associated box

Quantity

10540 units

Distribution

Worldwide distribution - US Nationwide and the country of Canada.

Lot, serial or model codes

UDI: 00887761985018, Lot Numbers: All lot numbers distributed beginning on 4/28/2025

510(k) numbers

["K192143","K200988"]

PMA numbers

not on file

Product code

NHJ

Firm FEI

1417572

Firm city

Deerfield

Firm state

IL

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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