Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

RUSCH CARE Premium Drain bag Recalled by Teleflex Medical Due to The device labels are not UDI compliant. The...

Date: January 14, 2019
Company: Teleflex Medical
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Teleflex Medical directly.

Affected Products

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

Quantity: 105426 US eaches

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Teleflex Medical

Teleflex Medical has 204 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report