RUSCH Urinary Drainage bag, 2000mlm REF 390060 urine collection device
Check against the official notice below — it lists the full affected range.
Teleflex Medical has recalled RUSCH Urinary Drainage bags (2000ml, REF 390060) totaling 76,725 units in the United States and distributed to Canada, Bolivia, Guatemala, Jamaica, Peru, Trinidad, and El Salvador. The recall was issued because the device labels do not comply with UDI (Unique Device Identification) requirements, though this labeling deficiency does not affect how the device functions or performs, and all other label information and warnings remain valid.
The affected product was distributed under GTIN 14026704645715 across multiple lot/batch numbers ranging from October 2016 through September 2017. The source does not specify what action affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: Worldwide Distribution: US (nationwide) and countries of: Canada, Bolivia, Guatemala, Jamaica, Peru, Trinidad, and El Salvador. Quantity: 76725 US eaches Lot/code info: GTIN: 14026704645715 Lot/Batch Numbers: 20161005 20161120 20161125 20170105 20170210 20170401 20170402 20170501 20170801 20170901 20170902 20170903 20170904 20171101 20170701
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.