FDA recall Z-1974-2019

Product

RUSCH CARE Premium Drain bag, 2000mlm REF 390000 urine collection device

Reason for recall

The device labels are not UDI compliant. The missing UDI compliance information on the labelling is not likely to affect the function/performance of the device itself. Other label information and warnings are unaffected by this labelling.

Distribution

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

Key facts

Status

Terminated

Initiation date

2019-01-14

Report date

2019-07-24

Termination date

2022-12-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Morrisville, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1974-2019