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 Fibr

Is my product affected?

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.

• UPC 50788942215304

Check against the official notice below — it lists the full affected range.

What happened

Smiths Medical ASD Inc. is recalling 4,440 units of the Portex Acapella DH Vibratory PEP Device, a single-patient-use device that provides Positive Expiratory Pressure therapy for patients with cystic fibrosis. The recall was initiated because shipping boxes may contain the wrong model of the device. The affected units have Model Number 21-1530, Lot Number 3988435, and UDI 50788942215304.

The recalled devices were distributed worldwide, including throughout the United States in multiple states (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 internationally in Austria, Canada, Chile, Czech Republic, France, Germany, Italy, and Thailand. The recall record does not specify a remedy or what affected consumers should do.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Shipping box may contain wrong model.

Details from the source

Reason for recall: Shipping box may contain wrong model. 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. Quantity: 4440 Lot/code info: Model Number 21-1530, Lot Number 3988435, UDI 50788942215304

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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