Recall Z-1954-2018— Draeger Medical, Inc.

Name: FDA recall Z-1954-2018
Creator: U.S. Food and Drug Administration
Published: 2018-04-26

Class II · Terminated

Class II FDA medical device recall by Draeger Medical, Inc., initiated 2018-04-26, terminated 2018-09-07. It names one FDA 510(k) clearance: K072885. Product: Carina Ventilator, ventilator. Catalog no. 5704110. Long-term ventilator for treatment in hospitals by a qualified medical personnel.. Reason: The valve assembly material may become corroded due to insufficient cleaning by a supplier. There is a risk of the breathing gas becoming contaminated in the affected devices..

Recalling firm: Draeger Medical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-04-26
Terminated: 2018-09-07
Firm location: Telford, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K072885 — CARINA SYSTEM, MODEL 8419350; CARINA BASIC DEVICE, MODEL 5704110Draeger Medical AG & Co. KG·cleared 2008-04-07

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

Carina Ventilator, ventilator. Catalog no. 5704110. Long-term ventilator for treatment in hospitals by a qualified medical personnel.

Reason for recall

The valve assembly material may become corroded due to insufficient cleaning by a supplier. There is a risk of the breathing gas becoming contaminated in the affected devices.

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