Z-0874-2021 Class II Terminated
FDA device recall Z-0874-2021 was initiated by Smiths Medical ASD Inc. on December 21, 2020 and is designated Class II. Reason for recall: Shipping box may contain wrong model. The recall status is terminated (terminated July 11, 2024). Affected quantity: 4440.
Recall Details
- Product Type
- Devices
- Report Date
- January 27, 2021
- Initiation Date
- December 21, 2020
- Termination Date
- July 11, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4440
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.
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.
Code Information
Model Number 21-1530, Lot Number 3988435, UDI 50788942215304