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U.S. Department of Health and Human Services

Class 2 Device Recall Aeroneb Go

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 Class 2 Device Recall Aeroneb Gosee related information
Date Initiated by FirmSeptember 07, 2004
Date PostedNovember 05, 2004
Recall Status1 Terminated 3 on August 24, 2005
Recall NumberZ-0177-05
Recall Event ID 30068
510(K)NumberK032849 
Product Classification Nebulizer (Direct Patient Interface) - Product Code CAF
ProductAeroneb Go Micropump Nebulizer Featuring OnQ electronic micropump, RX, Manufactured by Medical Industries America Inc., Adel, IA. The product is sold individually or in master packs of 8 under the following model numbers (all using the same box label): Model 7000 - Consisting of the Aeroneb Go, battery controller, battery controller cable, 3 AA alkaline batteries, mask elbow, mouthpiece, carry bag, and user manual; Model 7030 - Consisting of the Aeroneb Go, AC wall adapter, mask elbow, mouthpiece, carry bag, and user manual; Model 7070 - Consisting of the Aeroneb Go, battery controller, battery controller cable, 3 AA alkaline batteries, AC wall adapter, mask elbow, mouthpiece, carry bag, and user manual; Model 7000-1 - Consisting of the Aeroneb Go, battery controller, battery controller cable, 3 AA alkaline batteries, European mask elbow, mouthpiece, carry bag, and user manual; Model 7030-1 - Consisting of the Aeroneb Go, AC wall adapter, European mask elbow, mouthpiece, carry bag, and user manual; Model 7070-1 - Consisting of the Aeroneb Go, battery controller, battery controller cable, 3 AA alkaline batteries, AC wall adapter, European mask elbow, mouthpiece, carry bag, and user manual. 7000LINCARE - Consisting of the Aeroneb Go, battery controller with a Lincare private label cover plate, battery controller cable, 3 AA alkaline batteries, mask elbow, mouthpiece, carry bag, and user manual; 7070LINCARE - Consisting of the Aeroneb Go, battery controller with the Lincare private label cover plate, battery controller cable, 3 AA alkaline batteries, AC wall adapter, mask elbow, mouthpiece, carry bag, and user manual.
Code Information 040120, 040127, 040129, 040130, 040201, 040202, 040203, 040205, 040209, 040210, 040216, 040219, 040227, 040301, 040303, 040305, 040311, 040317, 040406, 040407, 040415, 040427, 040421, 040428, 040506, 040721, 040723, 040726, 040730, 080504, 080904, 081104, 081604, 081704, 081904, 082004, 082304, 082504, 082704, 083004, 083104, 080304
Recalling Firm/
Manufacturer		 Medical Industries America Inc
2636 289th Pl
Adel IA 50003-8021
For Additional Information ContactDan Bunting
515-993-5001 Ext. 214
Manufacturer Reason
for Recall		The nebulizer can either fail or provide a low flow (partial dose) of medication
FDA Determined
Cause 2		Other
ActionThe recalling firm initiated their action via telephone on 9/7/04 to the care providers to inform them of the product problem and that they would soon be receiving additional information about the recall. Between 9/24-28/04, the firm issued letters to their care providers with specific instructions as to how to decide what individuals would or would not need a backup generator in their possession. They were also instructed to pass the information onto the end user. On 10/1/04, the firm called the care providers and subsequently issued second letters or postcards to them to correct the toll free number that had been misprinted on the literature and letter.
Quantity in Commerce17,464 units
DistributionDistribution was made to home health care providers and pharmacies nationwide. Foreign distribution was made to Italy, Greece, France, Poland, Japan, Hong Kong, Argentina, Australia, Israel, and Singapore.
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 = CAF
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