Teleflex Medical: Medical Device Recall in 2019 - (Recall #: Z-1975-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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

Product Classification:

Class III

Date Initiated: January 14, 2019

Date Posted: July 24, 2019

Recall Number: Z-1975-2019

Event ID: 81954

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.

Status: Terminated

Product Quantity: 76725 US eaches

Code Information:

GTIN: 14026704645715 Lot/Batch Numbers: 20161005 20161120 20161125 20170105 20170210 20170401 20170402 20170501 20170801 20170901 20170902 20170903 20170904 20171101 20170701

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated