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Smiths Medical ASD Inc. Recall 87034

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.

Smiths Medical ASD Inc. Recall 87034 Information

StatusCompleted
Mandated?Voluntary: Firm initiated
Recall NumberZ-0874-2021
Event ID87034
Event DescriptionPortex 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.
Product TypeDevices
DistributionWorldwide 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.
Quantity4440
Recall ReasonShipping box may contain wrong model.
Device Classification20210127
Device Code InfoModel Number 21-1530, Lot Number 3988435, UDI 50788942215304
Center Classification Date20210115
Recall Initiation Date20201221
Recalling FirmSmiths Medical ASD Inc.
Initial Notification E-Mail
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