Recall Z-2248-2023— Draeger Medical, Inc.

Name: FDA recall Z-2248-2023
Creator: U.S. Food and Drug Administration
Published: 2023-07-12

Class I · Ongoing

Class I FDA medical device recall by Draeger Medical, Inc., initiated 2023-07-12. It names one FDA 510(k) clearance: K072885. Product: Carina Sub-Acute Care Ventilator. Reason: Presence of polyether polyurethane (PE-PUR) and emission of 1,3-Dichloropropan-2-ol that exceed the acceptable uptake level during continuous use (>30 days) in pediatric patients..

Recalling firm: Draeger Medical, Inc.
Classification: Class I
Status: Ongoing
Initiated: 2023-07-12
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 Sub-Acute Care Ventilator

Reason for recall

Presence of polyether polyurethane (PE-PUR) and emission of 1,3-Dichloropropan-2-ol that exceed the acceptable uptake level during continuous use (>30 days) in pediatric patients.

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