Recall Z-2781-2015— Salter Labs
Class II · Terminated
Class II FDA medical device recall by Salter Labs, initiated 2015-08-04, terminated 2016-05-06. It names 2 FDA 510(k) clearances: K962879, K961476. 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.. Reason: The Inspiratory valve cap on the nebulizer reservoir tower may be loose and may detach before or during treatment..
- Recalling firm
- Salter Labs
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-08-04
- Terminated
- 2016-05-06
- Firm location
- Carlsbad, CA, United States
510(k) clearances named in this recall
2 on FDA's record- K962879 — SALTERLABS 8660 SERIES NEBULIZER
- K961476 — SALTERLABS 8960 SERIES NEBULIZER (8960/8961/8966/8984)
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
The Inspiratory valve cap on the nebulizer reservoir tower may be loose and may detach before or during treatment.
Data sourced from openFDA. This site is unofficial and independent of the FDA.