SafeStar 90 Plus Filter. Bidirectionally breathing system filter.
Recall
- Recall Number
- Z-2158-2025
- Event Number
- 97026
- Firm
- Draeger, Inc.
- FEI Number
- 2517967
- Product Code
- CAH
- Status
- Open, Classified
- Root Cause
- Process control
- Initiated
- June 16, 2025
- Posted
- July 31, 2025
- Address
- 3135 Quarry Rd, Telford, PA, 18969-1042
Description
SafeStar 90 Plus Filter. Bidirectionally breathing system filter.
Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.
An initial Urgent Medical Device Recall notification dated June 2025 was mailed to consignees. The notification instructs consignees to not make therapeutic decisions based solely on individual measured values or parameters, regardless of the measuring point and the ventilator or anesthesia machine used. Consignees are to not connect the sample line to the filter sampling port; if an alternative sample port is not feasible, the firm requests that consignees use an alternative filter. All users of affected devices are to be notified of this recall notice and the notice forwarded to customers to which product was further distributed. Consignees are asked to complete and return the provided Response Acknowledgement and Receipt Form. Questions can be directed to Michael Kelhart at 267-664-1131 from 8:00 AM EST to 4:30 PM EST, or by email at [email protected]. A second Urgent Medical Device Recall notification dated July 2025 was mailed to consignees. This notification recommends that any unused filters affected by this recall not be used and any unused stock should be removed. Consignees are to contact their local Draeger Representative for information regarding alternatives. Draeger Customer Success can be contacted at 1-800-437-2437 (option 2, option 1) or [email protected] to coordinate return/replacement. This recall notification should be shared with all users and forwarded to where devices were further distributed.
Worldwide - US Nationwide distribution including in the states of AK, AZ, CA, CO, CT, FL, ID, IL, IN, KAS, LA, MA, ME, MI, MN, MO, NC, NE, NM, NV, NY, OH, PA, SD, TN, TX, UT, WA, WI, WY and the countries of Angola, Argentina, Australia, Austria, Belarus, Belgium, Bolivia, Bosnia-Herz., Brazil, Bulgaria, Burkina-Faso, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Rep., El Salvador, Faeroe, France, French Guiana, Gabon, Germany, Greece, Honduras, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Ivory Coast, Japan, Jordan, Kosovo, Kuwait, Latvia, Lebanon, Libya, Liechtenstein, Malaysia, Mali, Mexico, Moldavia, Mongolia, Morocco, Netherlands, New Zealand, Nigeria, North Macedonia, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad, Tobago, Turkey, Ukraine, United Kingdom, United Arab Emirates, Uzbekistan, Vietnam.
669,838 units