The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1371-2013·Announced 2013-06-05

FDA Recalls EZ Breathe Atomizers Due to Choking Hazard

Nephron Pharmaceuticals is recalling EZ Breathe Atomizers because a component may dislodge, creating a choking hazard.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Possible dislodgement of the "Plate A", if this instance occurs, it presents a potential choking hazard."

Plain-English summary

Nephron Pharmaceuticals Corp. is recalling 604 units of the EZ Breathe Atomizer, Model # EZ-100. This medical device is used for the delivery of liquid medications for respiratory usage.

The recall was initiated because the "Plate A" component of the atomizer may dislodge. If this occurs, it presents a potential choking hazard to the user.

The affected units were distributed nationwide in the United States, including DC and Puerto Rico, as well as in Guatemala, Poland, Panama, and the United Kingdom. Consumers should stop using the affected atomizers and contact the manufacturer for instructions on how to proceed.

The recalled product

Product
EZ Breathe Atomizer Model # EZ-100. For the delivery of liquid medications for respiratory usage.
Manufacturer
Nephron Pharmaceuticals Corp.
Category
Medical Device — Respiratory
Hazard
Affected units
604

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 (5)

  • Model # EZ-100 Lots # R2029A
  • R2029B
  • R2039A
  • R2042A
  • R2045A

Distribution

Distributed nationwide across the United States.

The notice also names 34 states specifically:

Part of a larger recall action

This product is one of 3 recalled by Nephron Pharmaceuticals Corp. 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 3 products in this recall →

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