Drager SafeStar 55, Catalog No. MP01790
- Company
- Draeger Medical, Inc.
- Recall Initiated
- May 16, 2022
- Recall Number
- Z-1211-2022
- Quantity
- 35,950
- Firm Location
- Telford, PA
Reason for Recall
Possible occlusion of filters due to manufacturing error.
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.
Lot / Code Info
UDI-DI: 04048675026785; Lot No. LT2103.
Root Cause
Process design
Action Taken
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.