Recall Z-0796-2016— Salter Labs

Name: FDA recall Z-0796-2016
Creator: U.S. Food and Drug Administration
Published: 2016-01-05

Class II · Terminated

Class II FDA medical device recall by Salter Labs, initiated 2016-01-05, terminated 2016-04-21. It names one FDA 510(k) clearance: K884947. Product: T-piece Nebulizer with in-line connectors, Part number 8915-7-50. Single patient use, non-sterile prescription device designed for use in a hospital or home care environment.. Reason: Reports that the T-piece does not fit on the nebulizer..

Recalling firm: Salter Labs
Classification: Class II
Status: Terminated
Initiated: 2016-01-05
Terminated: 2016-04-21
Firm location: Carlsbad, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K884947 — HAND HELD NEBULIZER SYSTEMSalter Labs·cleared 1989-02-17

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

T-piece Nebulizer with in-line connectors, Part number 8915-7-50. Single patient use, non-sterile prescription device designed for use in a hospital or home care environment.

Reason for recall

Reports that the T-piece does not fit on the nebulizer.

Data sourced from openFDA. This site is unofficial and independent of the FDA.