The Recall Desk
HighFDA (Devices)·Z-2781-2015·Announced 2015-09-23

Salter Labs NebuTech Nebulizers Recalled for Loose Inspiratory Valve Cap

Salter Labs is recalling specific NebuTech nebulizer models because the inspiratory valve cap may detach during treatment.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a mechanical defect that poses a risk of harm during use, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Salter Labs is recalling 8,975 units of the NebuTech Nebulizer, including models 8660, 8960, 8961, 8966, and 8984. These devices are used to generate aerosols for breathing in hospital and homecare environments. The affected units include specific nebulizer part numbers and the inspiratory valve cap (part number 600116).

The recall is due to a defect where the inspiratory valve cap on the nebulizer reservoir tower may be loose and could detach before or during treatment. The affected lot numbers range from 042015 through 070615A. The products were distributed nationwide in the US and in Greece, the UK, Belgium, Australia, and Switzerland.

Consumers and healthcare providers should stop using the affected nebulizers and contact Salter Labs for instructions on how to proceed.

The recalled product

Product
NebuTech Nebulizer, Model number: Series 8660, 8960, 8961, 8966, 8984. Nebulizer used to generate aerosols delivered directly to the patient for breathing. Designed to be used in either a hospital or homecare environment.
Manufacturer
Salter Labs
Affected units
8,975

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 (11)

  • Lot Numbers 042015 through 070615A Series 8660
  • 8960
  • 8961
  • 8966
  • 8984. Nebulizers (part numbers 8660-7
  • 8960-7
  • 8960TG-7
  • 8967-7
  • 8982-7
  • 8984-7)
  • Inspiratory valve cap (part number 600116).

Distribution

Distributed nationwide across the United States.

Same manufacturer · Salter Labs

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