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

Is my product affected?

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

• UPC 14026704645708

Check against the official notice below — it lists the full affected range.

What happened

Teleflex Medical is recalling RUSCH CARE Premium Drain bags (2000ml, REF 390000) because the device labels do not comply with UDI (Unique Device Identifier) requirements. The missing UDI compliance information on the labels is not expected to affect how the device functions or performs, and all other label information and warnings remain intact and unaffected by this labeling issue.

The recall affects approximately 105,426 units distributed nationwide in the United States as well as in Canada, Bolivia, Guatemala, Jamaica, Peru, Trinidad, and El Salvador. The affected products are identified by GTIN 14026704645708 and include the following lot/batch numbers: 20161005, 20161120, 20161125, 20170105, 20170210, 20170301, 20170401, 20170402, 20170501, 20170601, 20170801, 20170902, 20170904, 20171001, 20171101, 20171201, 20180101, 20170802, and 20170701. The source does not specify a remedy or recommended action for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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.

Details from the source

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. Quantity: 105426 US eaches Lot/code info: GTIN: 14026704645708 Lot/Batch Numbers: 20161005 20161120 20161125 20170105 20170210 20170301 20170401 20170402 20170501 20170601 20170801 20170902 20170904 20171001 20171101 20171201 20180101 20170802 20170701

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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