Z-0177-05

Aeroneb Go Micropump Nebulizer Featuring OnQ electronic micropump, RX, Manufactured by Medical Industries...

Name: Z-0177-05 Aeroneb Go Micropump Nebulizer Featuring OnQ electronic micropump, RX, Manufactured by Medical Industries...
Creator: Medical Industries America Inc
Published: 2004-09-07
License: https://open.fda.gov/license/

Medical Industries America, Inc. / initiated 2004-09-07 / Terminated

FDA source

Medical Industries America Inc began a recall of Aeroneb Go Micropump Nebulizer Featuring OnQ electronic micropump, RX, Manufactured by Medical Industries America Inc., Adel, IA. The product is sold... on 2004-09-07. The reason FDA records is "The nebulizer can either fail or provide a low flow (partial dose) of medication". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0177-05
Status: Terminated
Initiated: 2004-09-07
Posted: 2004-11-05
Terminated: 2005-08-24
Recalling firm: Medical Industries America, Inc.
Product: Aeroneb 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.
Product code: CAF Nebulizer (Direct Patient Interface)
Reason for recall: The nebulizer can either fail or provide a low flow (partial dose) of medication
FDA root cause: Other
Action: The 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 commerce: 17,464 units
Distribution: Distribution 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.
Product codes and lots: 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

Product code CAF

K032849Class IIAeroneb Go Nebulizer, Model Ag-Ag2000Aerogen, Inc. / cleared 2003-11-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)