Aeroneb Go Micropump Nebulizer Featuring OnQ electronic micropump, RX, Manufactured by Medical Industries America Inc.,
FDA device recall Z-0177-05 · posted 2004-11-05 · Terminated
Recall details
- Recalling firm
- Medical Industries America Inc
- Reason for recall
- The nebulizer can either fail or provide a low flow (partial dose) of medication
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- CAF
- Quantity affected
- 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 Singa
- Date initiated
- 2004-09-07
- Date posted
- 2004-11-05
- Date terminated
- 2005-08-24
- Location
- Adel, IA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AERONEB GO NEBULIZER, MODEL AG-AG2000 (K032849) | Aerogen, Inc. | 2003-11-21 |