Home / Recalls / Medical Devices
SunMed Holdings, LLC recalls Adult Manual Resuscitator with Medium Adult Mask, Bag REservoir, Filter, Manometer and 7 ft Oxygen Tubing, REF CPRM1116F
Recalled June 11, 2025 · FDA recall Z-1814-2025 · SunMed Holdings
Hazard
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. · FDA Class I
Units
11,358
Sold at
US Nationwide distribution via Medline.
Description
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.
Product
Adult Manual Resuscitator with Medium Adult Mask, Bag REservoir, Filter, Manometer and 7 ft Oxygen Tubing, REF CPRM1116F
Manufacturer(s)
SunMed Holdings, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →