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Recall Observatory FDA recall evidence

Device product

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

Z-1974-2019

January 14, 2019

Class III

Product summary

Firm
Teleflex Medical
Event
Event 81954
Status
Terminated
Classification
Class III
Quantity
105426 US eaches
Official record key
device-enforcement:Z-1974-2019

Official wording

Reason: 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.

Code information: GTIN: 14026704645708 Lot/Batch Numbers: 20161005 20161120 20161125 20170105 20170210 20170301 20170401 20170402 20170501 20170601 20170801 20170902 20170904 20171001 20171101 20171201 20180101 20170802 20170701

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.