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.
FDA Recall Z-0874-2021 · Posted None
Recalling FirmSmiths Medical ASD Inc.
Recall StatusTerminated
Product CodeBWF
Date Initiated2020-12-21
Date Terminated2024-07-11
Product Quantity4440
Reason for Recall
Shipping box may contain wrong model.
Firm Action
Urgent Medical Device Recall Notice (Ref # 3012307300-12/18/2020-014-R) will be sent to customers via tracked email during the week of December 21, 2020. Customers are instructed to send affected product to Smiths Medical.
Root Cause
Nonconforming Material/Component
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.