Recall Z-1211-2022 ยท CAH Filter, Bacterial, Breathing-Circuit
Draeger Medical, Inc.
Drager SafeStar 55, Catalog No. MP01790
| Date | May 16, 2022 |
| Status | Open, Classified |
| Reason | Possible occlusion of filters due to manufacturing error. |
| 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 th |
| Quantity | 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072002 | FILTER CARESTAR 30; FILTER SAFESTAR 55; FILTER/HME TWINSTAR 55 Draeger Medical AG & Co. KG, Jan 31, 2008 |