The Recall Desk
ModerateFDA (Devices)·Z-0121-2015·Announced 2014-10-29

Aerogen Nebulizer Power Adapter Recall Due to Broken Cover

Aerogen is recalling 323 FRIWO AC/DC power adapters for Aeroneb nebulizers because the cover broke and dislodged from the adapter body.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a broken cover on a power adapter, which presents a risk of electrical shock or injury but is not associated with reported deaths or serious injuries in the source text.

Plain-English summary

Aerogen Ltd. is recalling 323 FRIWO AC/DC power adapters (Model Number: GPP10) used in the Aeroneb Solo and Pro Nebulizer systems. The recall is due to a small number of complaints indicating that the power adapter cover had broken and dislodged from the body of the adapter prior to use.

The affected adapters were supplied with specific Aeroneb Nebulizer systems, including models AG-UC1000-NE, AG-UC1000-UK, AG-UC1500-NE, AG-UC1500-SC, and AG-UC1500-SE. The products were distributed worldwide, including nationwide in the United States and in numerous international markets.

Consumers should stop using the affected power adapters immediately. The source text does not specify further remediation steps or contact information for the recall.

The recalled product

Product
The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation or other positive pressure breathing assistance. The Aeroneb Professiona
Manufacturer
Aerogen Ltd.
Category
Medical Device — Nebulizer Accessories
Hazard
Affected units
323

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (17)

  • FRIWO AC/DC Adapter Model Number: GPP10
  • Lot Numbers: 9263140718116
  • 9263140718137
  • 9263140730049
  • 2) Model Number: AG-UC1000-UK
  • Lot Numbers: 9235140718022
  • 9235140718093
  • 9235140718154
  • 3) Model Number: AG-UC1500-NE
  • Lot Numbers: 9264140627057
  • 9264140627100
  • 9264140721112
  • 9264140724100
  • 4) Model Number: AG-UC1500-SC
  • Lot Numbers: 9277140721040
  • 5) Model Number: AG-UC1500-SE
  • Lot Numbers: 9276140731046

Distribution

Distributed nationwide across the United States.

The notice also names 6 states specifically:

Part of a larger recall action

This product is one of 4 recalled by Aerogen Ltd. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Related recalls

Same manufacturer · Aerogen Ltd.

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Same hazard · electrical shock

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