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Recall Observatory FDA recall evidence

Device 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.

Z-0874-2021

December 21, 2020

Class II

Product summary

Firm
Smiths Medical ASD Inc.
Event
Event 87034
Status
Terminated
Classification
Class II
Quantity
4440
Official record key
device-enforcement:Z-0874-2021

Official wording

Reason: Shipping box may contain wrong model.

Code information: Model Number 21-1530, Lot Number 3988435, UDI 50788942215304

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Shipping box may contain wrong model.