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Halyard 13481Recalls & reported problems

Avanos Medical, Inc. · SURGPN,400X2-14,CB SAF,-,OQ,5 · Class 2

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 10680651134810), received between Feb 20, 2017 and Feb 20, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Excess Flow or Over-Infusion” (1 report).

3 other recalls cover devices cleared under the same FDA submission (K063530); 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

  • Excess Flow or Over-Infusion1

Patient problems

  • No Code Available1

Recent adverse event reports

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

  • MalfunctionFeb 20, 2017Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

    FILL VOLUME: 400 ML, FLOW RATE: 2-14 ML/HR, PROCEDURE: UNKNOWN, CATHPLACE: UNKNOWN. IT WAS REPORTED THAT A PATIENT EXPERIENCED A HIGH FLOW RATE EVENT ASSOCIATED WITH THE USE OF A ELASTOMERIC INFUSION PUMP. IT WAS ALSO NOTED THAT THERE WAS A "BLOCKNESS OF THE UPPER PART OF THE LEG." NO FURTHER INFORMATION WAS RECEIVED.

    Patient problems: No Code Available

    MAUDE report 6343114 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K063530. One submission often covers many models, so check the product and lot details in each record.

  • Z-2860-2011 · Apr 15, 2011 · Terminated
    I-Flow ON-Q with Select-A-Flow Pumps, Intended for continuous and/or intermittent delivery of medication to and around surgical wound sites and/or close proximity to nerves for p
  • Z-2133-2008 · Feb 14, 2008 · Terminated
    On-Q C-bloc 400 ml, 1-7 ml/hr Select-A-Flow + 5 ml/60 min ONDEMAND, REF CB005 indicated for continuous and/or intermittent delivery of medication (such as local anesthetics or narc
  • Z-1869-2008 · Feb 12, 2008 · Terminated
    ON-Q PainBuster Infusion Pump (270 ml, 5 ml/hr), REF PS6504, Part No. 5001260. The pump is indicated for continuous and/or intermittent delivery of medication (such as local anest

Other PUMP, INFUSION, ELASTOMERIC devices

All PUMP, INFUSION, ELASTOMERIC devices →

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