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 21-1530Lot Number 3988435UDI 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.
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