Class 1 Device Recall Drager SafeStar 55, Catalog No. MP01790

• Date Initiated by Firm: May 16, 2022
• Create Date: June 10, 2022
• Recall Status: Open, Classified
• Recall Number: Z-1211-2022
• Recall Event ID: 90192
• 510(K)Number: K072002
• Product Classification: Filter, bacterial, breathing-circuit - Product Code CAH
• Product: Drager SafeStar 55, Catalog No. MP01790
• Code Information: UDI-DI: 04048675026785; Lot No. LT2103.
• Recalling Firm/ Manufacturer: Draeger Medical, Inc.; 3135 Quarry Rd; Telford PA 18969-1042
• For Additional Information Contact: Michael A. Kelhart; 215-660-2349
• Manufacturer Reason for Recall: Possible occlusion of filters due to manufacturing error.
• FDA Determined 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = CAH and Original Applicant = DRAEGER MEDICAL AG & CO. KG