Reported Jun 11, 2025 · Ongoing
Adult Manual Resuscitator with Medium Adult Mask, Bag REservoir, Filter, Manometer and 7 ft Oxygen Tubing, REF CPRM1116F
SunMed Holdings, LLC
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: SunMed Holdings, LLC · 2710 Northridge Dr Nw Ste A · Grand Rapids, MI · 49544-9112
Is this the product you have?
- Adult Manual Resuscitator with Medium Adult Mask, Bag REservoir, Filter, Manometer and 7 ft Oxygen Tubing, REF CPRM1116F
- Lot codes and dates
- UDI-DIEA: 10884389164822
- CS40884389164823
- Lots
526782526790526796526797526798526800526802526804526805526806526807526808526809526810526814526815526816526811526817526818
- Amount recalled
- 11,358
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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