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
Product summary
- 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
Shipping box may contain wrong model.