Z-1211-2022Class I

Drager SafeStar 55, Catalog No. MP01790

Name: Z-1211-2022 Drager SafeStar 55, Catalog No. MP01790
Creator: Draeger Medical, Inc.
Published: 2022-05-16
License: https://open.fda.gov/license/

Draeger, Inc. / initiated 2022-05-16 / Open, Classified / root cause: manufacturing process

FDA source

Draeger Medical, Inc. began a recall of Drager SafeStar 55, Catalog No. MP01790 on 2022-05-16. FDA classified it as Class I and gives the reason as "Possible occlusion of filters due to manufacturing error". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1211-2022
Classification: Class I
Status: Open, Classified
Initiated: 2022-05-16
Posted: 2022-06-10
Recalling firm: Draeger, Inc.
Product: Drager SafeStar 55, Catalog No. MP01790
Product code: CAH Filter, Bacterial, Breathing-Circuit
Reason for recall: Possible occlusion of filters due to manufacturing error.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: The firm distributed a notification titled "URGENT MEDICAL DEVICE RECALL" by mail on 05/16/2022, in which it informed customers of the voluntary recall of Lot LT2103 of Draeger SafeStar 55 Breathing System Filters, Ref. No. MP01790, UDI-DI 04048675026785. The firm states that this recall is being initiated in response to becoming aware of a complaint in which a patient became hypoxic and had to be resuscitated while under anesthesia using the Draeger SafeStar 55 Breathing System Filter from the affected lot. The firm indicated that a manufacturing feature that automatically destroys filters that fail acceptance testing was disabled during servicing, which resulted in filters having to be hand sorted during manufacturing of Lot LT2103. Drager is asking customers to check their inventory for SafeStar 55 breathing system filters from Lot LT2103. If any affected product is on hand, customers are to call Draeger Customer Service at 1-80-437-2437, fax at 1-215-723-5935, or email at US-Medical@draeger to obtain free replacement of product. If any affected product is on hand, customers are to segregate and quarantine product until Draeger's provision of a return materials authorization and pre-paid shipping labels. Draeger also asks customers to make the recall notification available within their organization and to forward a copy if product was further distributed. A Customer Acknowledgement Form was provided with the notification for all customers to complete and return. Customers with any questions are to contact Michael Kelhart, Quality Director, between the hours of 8:00 AM and 4:30 PM EST at 1-800-437-2437, press 1, then 32349.
Quantity in commerce: 35,950
Distribution: Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, CT, FL, GA, IL, IN, KY, LA, MA, MD, MI, MN, NC, ND, NV, NY, OH, PA, TN, TX, WA, and WV. The countries of Austria, Belgium, Bulgaria, Canada, Columbia, Croatia, Czech Republic, Denmark, France, Germany, India, Indonesia, Ireland, Italy, Ivory Coast, Japan, Kazakhstan, Latvia, Malaysia, Morocco, Netherlands, Norway, Philippines, Portugal, Romania, Russian Federation, Saudi Arabia, Serbia, Slovakia, South Africa, South Korea, Spain, Suriname, Sweden, Switzerland, Thailand, United Kingdom, and United Arab Emirates.
Product codes and lots: UDI-DI: 04048675026785; Lot No. LT2103.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1211-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1211-2022	Class I	Ongoing	Voluntary: Firm initiated	2022-06-22	2022-06-10

Product code CAH

K072002Class IIFilter Carestar 30; Filter Safestar 55; Filter/hme Twinstar 55Draeger Medical AG & Co. KG / cleared 2008-01-31

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)