Smiths Medical Recalls Portex Acapella DH Vibratory PEP Devices
Smiths Medical ASD Inc. is recalling 4,440 Portex Acapella DH Vibratory PEP Devices because shipping boxes may contain the wrong model number.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a potential labeling or packaging error (wrong model in box) without reported injuries or illnesses, fitting the Moderate severity criteria for minor labeling errors or low-risk issues.
Plain-English summary
Smiths Medical ASD Inc. is recalling 4,440 units of the Portex Acapella DH Vibratory PEP Device. The recall is due to a potential shipping error where the box may contain a device with the wrong model number.
The affected devices are identified by Model Number 21-1530, Lot Number 3988435, and UDI 50788942215304. The devices were distributed worldwide, including nationwide in the United States and in specific countries such as Austria, Canada, Chile, the Czech Republic, France, Germany, Italy, and Thailand.
The Portex Acapella DH is a single-patient-use device used to provide Positive Expiratory Pressure (PEP) Therapy for patients with conditions such as Cystic Fibrosis, COPD, asthma, and other lung diseases with secretory problems. Patients and healthcare providers should verify the model number of the device against the packaging to ensure the correct unit is being used.
The recalled product
- Product
- 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.
- Manufacturer
- Smiths Medical ASD Inc.
- Hazard
- Affected units
- 4,440
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Model Number 21-1530
- Lot Number 3988435
- UDI 50788942215304
Distribution
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