—#185082

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.

FDA product code: BWF — Spirometer, Therapeutic (Incentive)
Device class: Class 2
Medical specialty: Anesthesiology
510(k) numbers: K002768
Affected lot / code info: Model Number 21-1530, Lot Number 3988435, UDI 50788942215304

Why it was recalled

Shipping box may contain wrong model.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Smiths Medical ASD Inc.
Address: 6000 Nathan Ln N, Minneapolis, Minnesota 55442-1690

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2020-12-21
Terminated: 2024-07-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #185082. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.