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Smiths Medical ASD Inc. recalls Portex Acapella DH Vibratory PEP Device - Product Usage: a single patient use device that provides Positive Expiratory P
Recalled January 27, 2021 · FDA recall Z-0874-2021 · Smiths Medical ASD
Hazard
Shipping box may contain wrong model. · FDA Class II
Units
4440
Sold at
Worldwide distribution - US Nationwide distribution including in the states of AL, AZ, CA, CO, FL, GA, IA, IL, IN, KS, MD, ME, MI, MO, MS, NC, NE, NJ, OH, OR, PA, SC, TN, TX, UT, VA, WV and the countries of Austria, Canada, Chile, Czech Republic, France, Germany, Italy, Thailand.
Description
Shipping box may contain wrong model.
Product
Portex Acapella DH Vibratory PEP Device - Product Usage: a 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.
Manufacturer(s)
Smiths Medical ASD Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →