Recall Z-0874-2021 ยท BWF Spirometer, Therapeutic (Incentive)
Smiths Medical ASD Inc.
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.
| Date | Dec 21, 2020 |
| Status | Terminated |
| Reason | Shipping box may contain wrong model. |
| Root cause | Nonconforming Material/Component |
| Action | Urgent Medical Device Recall Notice (Ref # 3012307300-12/18/2020-014-R) will be sent to customers via tracked email during the week of December 21, 2020. Customers are instructed to send affected product to Smiths Medical. |
| Quantity | 4440 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K002768 | ACAPELLA Dhd Healthcare Corp., Dec 5, 2000 |