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.
Recall
- Recall Number
- Z-0874-2021
- Event Number
- 87034
- Firm
- Smiths Medical ASD Inc.
- FEI Number
- 3012307300
- Product Code
- BWF
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- December 21, 2020
- Terminated
- July 11, 2024
- Address
- 6000 Nathan Ln N, Minneapolis, MN, 55442-1690
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.
Shipping box may contain wrong model.
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.
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.
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