Portex recallZ-0874-2021 · Smiths Medical ASD Inc. · initiated Dec 21, 2020
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Smiths Medical ASD Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Shipping box may contain wrong model.
FDA root cause category: Nonconforming Material/Component
What the company is doing
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.
Recall details
- Recall number
- Z-0874-2021
- Status
- Terminated
- Initiated by the company
- Dec 21, 2020
- Recalling firm
- Smiths Medical ASD Inc.
- Quantity
- 4440
- Product code
- BWF
- FDA submissions
- K002768
- 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.
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.
Code information (models, lots, serial numbers)
Model Number 21-1530, Lot Number 3988435, UDI 50788942215304
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Portex 21-1530Icu Medical, Inc. · SPIROMETER, THERAPEUTIC (INCENTIVE)1 recall1 report
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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