Portex Acapella DH Vibratory PEP Device - Product recall
Portex Acapella DH Vibratory PEP Device - Product Usage: a single patient use device that provides Positive Expiratory Pressure (PEP) Therapy for…
Why was Portex Acapella DH Vibratory PEP Device - Product recalled?
Shipping box may contain wrong model.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model Number 21-1530, Lot Number 3988435, UDI 50788942215304
- Product
- Portex Acapella DH Vibratory PEP Device - Product Usage: a single patient use device that provides Positive Expiratory Pressure (PEP) Therapy for…
- Recalling firm
- Smiths Medical ASD Inc.
- 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.
- Recall date
- January 27, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)