Portex Acapella DH Vibratory PEP Device - Product Usage: a single patient use device that provide...
FDA Recall #Z-0874-2021 — Class II — December 21, 2020
Product Description
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.
Reason for Recall
Shipping box may contain wrong model.
Recalling Firm
Smiths Medical ASD Inc. — Minneapolis, MN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
4440
Distribution
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.
Code Information
Model Number 21-1530, Lot Number 3988435, UDI 50788942215304
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated