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HUDSON RCI IPN049869Recalls & reported problems

Teleflex Incorporated · Breathing Bag, 2 Liter · Class 1

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 14026704641373), received between Aug 10, 2021 and Aug 10, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Puncture/Hole” (1 report).

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.

Most reported problems

Device problems

  • Material Puncture/Hole1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 10, 2021Material Puncture/Hole; Material Puncture/Hole

    IT WAS REPORTED "DURING THE VENTILATION TO THE PATIENT, THEY REALIZED THAT THERE WAS A LEAK IN THE SYSTEM AND OBSERVED THAT THE BREATHING BAG HAD A HOLE". NO PATIENT INJURY, HARM, OR DESATURATION REPORTED. PATIENT CONDITION REPORTED AS "FINE".

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12300310 ↗

Other BAG, RESERVOIR devices

All BAG, RESERVOIR devices →

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