Recall Z-2690-2024— Breas Medical, Inc.

Name: FDA recall Z-2690-2024
Creator: U.S. Food and Drug Administration
Published: 2024-07-25

Class I · Ongoing

Class I FDA medical device recall by Breas Medical, Inc., initiated 2024-07-25. It names one FDA 510(k) clearance: K193586. Product: Vivo 45 LS, pressure and volume ventilator capable of delivering continuous or intermittent ventilatory support for patients who require invasive or non-invasive mechanical ventilation, Model/Catalog Number: 230000 (230016, 230216). Reason: There is a potential for short term (<7 days) elevated levels of formaldehyde emitted from the device into the patient breathing airpath in specific conditions..

Recalling firm: Breas Medical, Inc.
Classification: Class I
Status: Ongoing
Initiated: 2024-07-25
Firm location: North Billerica, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K193586 — Vivo 45 LSBreas Medical AB·cleared 2021-01-27

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Vivo 45 LS, pressure and volume ventilator capable of delivering continuous or intermittent ventilatory support for patients who require invasive or non-invasive mechanical ventilation, Model/Catalog Number: 230000 (230016, 230216)

Reason for recall

There is a potential for short term (<7 days) elevated levels of formaldehyde emitted from the device into the patient breathing airpath in specific conditions.

Data sourced from openFDA. This site is unofficial and independent of the FDA.