Recall Z-1975-2019— Teleflex Medical

Name: FDA recall Z-1975-2019
Creator: U.S. Food and Drug Administration
Published: 2019-01-14

Class III · Terminated

Class III FDA medical device recall by Teleflex Medical, initiated 2019-01-14, terminated 2022-12-13. FDA's recall record names no specific 510(k) clearance for this event. Product: RUSCH Urinary Drainage bag, 2000mlm REF 390060 urine collection device. Reason: 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..

Recalling firm: Teleflex Medical
Classification: Class III
Status: Terminated
Initiated: 2019-01-14
Terminated: 2022-12-13
Firm location: Morrisville, NC, United States

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.