Teleflex Medical recalls RUSCH Urinary Drainage bag, 2000mlm REF 390060 urine collection device

Recall date

January 14, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1975-2019

FDA classification

Class III

Brand / firm

Teleflex Medical

Sold / distributed

Worldwide Distribution: US (nationwide) and countries of: Canada, Bolivia, Guatemala, Jamaica, Peru, Trinidad, and El Salvador.

Why it was recalled

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.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

RUSCH Urinary Drainage bag, 2000mlm REF 390060 urine collection device