Recall Z-1211-2022— Draeger Medical, Inc.

Name: FDA recall Z-1211-2022
Creator: U.S. Food and Drug Administration
Published: 2022-05-16

Class I · Ongoing

Class I FDA medical device recall by Draeger Medical, Inc., initiated 2022-05-16. It names one FDA 510(k) clearance: K072002. Product: Drager SafeStar 55, Catalog No. MP01790. Reason: Possible occlusion of filters due to manufacturing error..

Recalling firm: Draeger Medical, Inc.
Classification: Class I
Status: Ongoing
Initiated: 2022-05-16
Firm location: Telford, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K072002 — FILTER CARESTAR 30; FILTER SAFESTAR 55; FILTER/HME TWINSTAR 55Draeger Medical AG & Co. KG·cleared 2008-01-31

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

Drager SafeStar 55, Catalog No. MP01790

Reason for recall

Possible occlusion of filters due to manufacturing error.

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