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Portex 8506PRecalls & reported problems

Icu Medical, Inc. · Class 2

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10351688431295), received between Apr 12, 2021 and Apr 12, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (2 reports).

3 other recalls cover devices cleared under the same FDA submission (K014115); they may or may not involve this specific model.

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

  • Physical Resistance/Sticking2

Patient problems

  • No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 12, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

    IT WAS REPORTED THAT THE RESUSCITATOR MASK WAS DIFFICULT TO REMOVE FROM THE PACKAGING. THE MASK WAS STICKING TO THE INNER BAG. THIS WAS DELAYING THERAPY. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11653044 ↗
  • MalfunctionApr 12, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

    IT WAS REPORTED THAT THE RESUSCITATOR MASK WAS DIFFICULT TO REMOVE FROM THE PACKAGING. THE MASK WAS STICKING TO THE INNER BAG. THIS WAS DELAYING THERAPY. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11652658 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K014115. One submission often covers many models, so check the product and lot details in each record.

  • Z-0810-03 · Nov 15, 2002 · Terminated
    Portex 1st Response Adult Manual Resuscitators Ref: 8503P
  • Z-0809-03 · Nov 15, 2002 · Terminated
    Portex 1st Response Adult Manual Resuscitators Ref: 8500P
  • Z-0808-03 · Nov 15, 2002 · Terminated
    Portex 1st Response Adult Manual Resuscitators Ref: 8506P

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.