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Curaplex AF3000Recalls & reported problems

Bound Tree Medical, LLC · Curaplex Infant Premium BVM w/ Bag Reservoir, Manometer, 25cm Pop-off, Filter & 2 Masks · Class 2

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. Oct 11, 2023Open, Classified

    A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.

    Z-0368-2024 · Root cause: Device Design · FDA record ↗

Other Ventilator, emergency, manual (resuscitator) devices

All Ventilator, emergency, manual (resuscitator) devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.