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U.S. Department of Health and Human Services

Class 2 Device Recall Portex Acapella DH Vibratory PEP Device

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 Class 2 Device Recall Portex Acapella DH Vibratory PEP Devicesee related information
Date Initiated by FirmDecember 21, 2020
Create DateJanuary 15, 2021
Recall Status1 Terminated 3 on July 11, 2024
Recall NumberZ-0874-2021
Recall Event ID 87034
510(K)NumberK002768 
Product Classification Spirometer, therapeutic (incentive) - Product Code BWF
ProductPortex 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.
Code Information Model Number 21-1530, Lot Number 3988435, UDI 50788942215304
FEI Number 3012307300
Recalling Firm/
Manufacturer		 Smiths Medical ASD Inc.
6000 Nathan Ln N
Minneapolis MN 55442-1690
For Additional Information ContactDavid Halverson
763-383-3072
Manufacturer Reason
for Recall		Shipping box may contain wrong model.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionUrgent 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.
Quantity in Commerce4440
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = BWF
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