Reported Jan 27, 2021 · Terminated

Portex Acapella DH Vibratory PEP Device - Product Usage: a single patient use device that provides Positive Expiratory…

Smiths Medical ASD 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: Smiths Medical ASD Inc. · 6000 Nathan Ln N · Minneapolis, MN · 55442-1690

Is this the product you have?

  • Portex Acapella
  • DH Vibratory PEP Device - Product Usagea single patient use device that provides Positive Expiratory Pressure (PEP) Therapy for patients who have Cystic Fibrosis, COPD, asthma, and lung diseases with secretory problems, and patients with atelectasis
Lot codes and dates
    • Model Number 21-1530
    • Lot Number 3988435
    • UDI 50788942215304
Amount recalled
4440

Where it was sold

Why it was recalled

Shipping box may contain wrong model.

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

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new Smiths Medical ASD Inc. recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

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

Read the FDA (openFDA device enforcement) notice

Notice updated Jul 11, 2024 · Data as of Sep 19, 6:53 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.