Recall Z-0177-05 ยท CAF Nebulizer (Direct Patient Interface)
Medical Industries America Inc
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
| Date | Nov 5, 2004 (initiated Sep 7, 2004) |
| Status | Terminated |
| Reason | The nebulizer can either fail or provide a low flow (partial dose) of medication |
| 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 |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032849 | AERONEB GO NEBULIZER, MODEL AG-AG2000 Aerogen, Inc., Nov 21, 2003 |