Recall Z-1814-2025 ยท BTM Ventilator, Emergency, Manual (Resuscitator)
SunMed Holdings, LLC
Adult Manual Resuscitator with Medium Adult Mask, Bag REservoir, Filter, Manometer and 7 ft Oxygen Tubing, REF CPRM1116F
| Date | May 30, 2025 (initiated May 1, 2025) |
| Status | Open, Classified |
| Reason | Affected lots were manufactured with B/V Filter incorrectly attached to the wrong port (patient port instead of the exhalation port). If not noticed prior to patient use, there would be interruption or delay in patient resuscitation, which may lead to life threatening consequences, including hypoxia, hypercapnia, organ failure, and death. |
| Root cause | Process control |
| Action | Recall initiated May 1, 2025. Customers instructed to immediately cease use of any affected product and quarantine all affected product. Customers were instructed to return or destroy affected product. AirLife will send new replacement product to customers once disposition is confirmed. If you need replacement products to be sent to you urgently, please call AirLife directly on 1-800-433-2797 and the firm will make every effort to accommodate your needs. |
| Quantity | 11,358 |
| Distribution | US Nationwide distribution via Medline. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K953546 | MANUAL PULMONARY RESUSICITATOR Medical Marketing Concepts, Feb 29, 1996 |