Recall Z-0874-2021— Smiths Medical ASD Inc.

Name: FDA recall Z-0874-2021
Creator: U.S. Food and Drug Administration
Published: 2020-12-21

Class II · Terminated

Class II FDA medical device recall by Smiths Medical ASD Inc., initiated 2020-12-21, terminated 2024-07-11. It names one FDA 510(k) clearance: K002768. 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.. Reason: Shipping box may contain wrong model..

Recalling firm: Smiths Medical ASD Inc.
Classification: Class II
Status: Terminated
Initiated: 2020-12-21
Terminated: 2024-07-11
Firm location: Minneapolis, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K002768 — ACAPELLADhd Healthcare Corp.·cleared 2000-12-05

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Reason for recall

Shipping box may contain wrong model.

Data sourced from openFDA. This site is unofficial and independent of the FDA.