Z-2781-2015Class II

NebuTech Nebulizer, Model number: Series 8660, 8960, 8961, 8966, 8984. Nebulizer used to generate aerosols...

Name: Z-2781-2015 NebuTech Nebulizer, Model number: Series 8660, 8960, 8961, 8966, 8984. Nebulizer used to generate aerosols...
Creator: Salter Labs
Published: 2015-08-04
License: https://open.fda.gov/license/

Salter Labs / initiated 2015-08-04 / Terminated

FDA source

Salter Labs began a recall of NebuTech Nebulizer, Model number: Series 8660, 8960, 8961, 8966, 8984. Nebulizer used to generate aerosols delivered directly to the patient for breathing... on 2015-08-04. FDA classified it as Class II and gives the reason as "The Inspiratory valve cap on the nebulizer reservoir tower may be loose and may detach before or during treatment". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2781-2015
Classification: Class II
Status: Terminated
Initiated: 2015-08-04
Posted: 2015-09-17
Terminated: 2016-05-06
Recalling firm: Salter Labs
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.
Product code: CAF Nebulizer (Direct Patient Interface)
Reason for recall: The Inspiratory valve cap on the nebulizer reservoir tower may be loose and may detach before or during treatment.
FDA root cause: Component change control
Action: Salter Labs sent a Medical Device Recall letter dated July 24 2015. The letter identified the affected product, problem and actions to be taken. The letter states that all affected product can be returned to Salter Labs for replacement at no charge with product specifically inspected for a tighter fit on the inspiratory valve cap. Customers were instructed to complete and return the Return Response Form as soon as possible. For any questions contact Salter Labs Customer Support at 800-421-0024 or the local Salter Labs representative.
Quantity in commerce: 8,975
Distribution: Worldwide Distribution - US Nationwide and in the countries of Greece, UK, Belgium, Australia, and Switerzland.
Product codes and lots: 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).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2781-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2781-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-23	2015-09-17

Product code CAF

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)