FDA-Device2019-07-24Class III
RUSCH Urinary Drainage bag, 2000mlm REF 390060 urine collection device
Teleflex Medical
Hazard
The device labels are not UDI compliant. The missing UDI compliance information on the labelling would not affect the function/performance of the device itself. Other label information and warnings are unaffected by this labelling.
Sold states
Worldwide Distribution: US (nationwide) and countries of: Canada, Bolivia, Guatemala, Jamaica, Peru, Trinidad, and El Salvador.
Affected count
76725 US eaches
Manufactured in
3015 Carrington Mill Blvd, N/A, Morrisville, NC, United States
Products
RUSCH Urinary Drainage bag, 2000mlm REF 390060 urine collection device
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1975-2019Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief