Reported Nov 29, 2023 · Ongoing

AVANOS BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI, Product code 221038, provide suction on patients on…

Avanos Medical, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

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: Avanos Medical, Inc. · 5405 Windward Pkwy · Alpharetta, GA · 30004-3894

Is this the product you have?

  • AVANOS BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI, Product code 221038, provide suction on patients on mechanical ventilation
Lot codes and dates
  • UDI/DI 00609038945064
  • Lot Numbers
    • 30112716
    • 30122936
    • 30116495
    • 30122179
    • 30116496
    • 30124942
    • 30117487
    • 30126227
    • 30117488
    • 30124946
    • 30117632
    • 30127429
    • 30117633
    • 30127494
    • 30113925
    • 30137504
    • 30119101
    • 30153170
    • 30119102
    • 30151042
    • 30116223
    • 30194152
    • 30123991
Amount recalled
4730 cases (94600 devices)

Why it was recalled

Certain lots of BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI were labeled as not being made with Di(2-ethylhexyl) phthalate (DEHP); however, Avanos has determined that the tubing components of the product did contain DEHP.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:58 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.