Recall Z-1138-2023— Draeger Medical, Inc.

Name: FDA recall Z-1138-2023
Creator: U.S. Food and Drug Administration
Published: 2023-01-23

Class I · Ongoing

Class I FDA medical device recall by Draeger Medical, Inc., initiated 2023-01-23. It names one FDA 510(k) clearance: K081743. Product: NovaStar TS, Standard elbow, Reusable, Material Numbers MP01579 (Size S), MP01580 (Size M), and MP01581 (Size L). Reason: The magnets used in the swivel frame/tube set and the headgear clips might impact medical devices (implanted as well as not implanted) and metallic implants..

Recalling firm: Draeger Medical, Inc.
Classification: Class I
Status: Ongoing
Initiated: 2023-01-23
Firm location: Telford, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K081743 — CLASSICSTAR NV SE AND NOVASTAR NV SE AND AAV FULL FACE MASKSDraeger Medical AG & Co. KG·cleared 2008-09-22

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

NovaStar TS, Standard elbow, Reusable, Material Numbers MP01579 (Size S), MP01580 (Size M), and MP01581 (Size L)

Reason for recall

The magnets used in the swivel frame/tube set and the headgear clips might impact medical devices (implanted as well as not implanted) and metallic implants.

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