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
| Status | Completed |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0874-2021 |
| Event ID | 87034 |
| Event 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. |
| Product Type | Devices |
| 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. |
| Quantity | 4440 |
| Recall Reason | Shipping box may contain wrong model. |
| Device Classification | 20210127 |
| Device Code Info | Model Number 21-1530, Lot Number 3988435, UDI 50788942215304 |
| Center Classification Date | 20210115 |
| Recall Initiation Date | 20201221 |
| Recalling Firm | Smiths Medical ASD Inc. |
| Initial Notification | |
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