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

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: Worldwide distribution - US Nationwide and the country of Canada. Quantity: 10540 units Lot/code info: UDI: 00887761985018, Lot Numbers: All lot numbers distributed beginning on 4/28/2025

UPC codes

00887761985018

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.