CLASS III Device recall · Reported 22 Jan 2020 · FDA Enforcement Report

RuSCH One piece Male External Medium Catheter W/O Tape recalled

Teleflex Medical is recalling RuSCH One piece Male External Medium Catheter W/O Tape, distributed in 11 states. The recall was initiated on 27 Feb 2019 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesGTIN 24026704549843 Lot Numbers: 74A1800577, 74G1802121, 74A1801939, 74H1700894, 74B1800363, 74J1700864, 74B1801604, 74J1702489, 74B1802746, 74C1801178, 74K1702257, 74L1700074, 74C1801294 , 74L1701701, 74C1802132, 74M1700121, 74G1800047, 74M1701150, 74G1800891, 74M1701769, 74G1801166

Quantity recalled13104 devices

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0797-2020
FDA event ID: 82307
Recalling firm: Teleflex Medical, Morrisville, NC
Classification: Class III
Status: Terminated
Recall initiated: 27 Feb 2019
FDA classified: 10 Jan 2020
Reported: 22 Jan 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Heart & Vascular Devices

Timeline

27 Feb 2019	Recall initiated by company
10 Jan 2020	Classified by FDA	+317 days
22 Jan 2020	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The device label incorrectly states that the device is sterile. This product is an externally applied male condom-type catheter designed for the management of male incontinence as an alternative to incontinence pads. In normal use, the device is neither expected nor required to be sterile.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Teleflex MEDICAL RuSCH One piece Male External Medium Catheter W/O Tape, REF A1500M

Where it was distributed

ME,NC, WA, MO, NJ, FL, CAL, TX, OH, IL, MA, GA, FL, GA, Canada

Florida Georgia Illinois Massachusetts Maine Missouri North Carolina New Jersey Ohio Texas Washington

Questions about this recall

Why was it recalled?

Which lots are affected?

GTIN 24026704549843 Lot Numbers: 74A1800577, 74G1802121, 74A1801939, 74H1700894, 74B1800363, 74J1700864, 74B1801604, 74J1702489, 74B1802746, 74C1801178, 74K1702257, 74L1700074, 74C1801294 , 74L1701701, 74C1802132, 74M1700121, 74G1800047, 74M1701150, 74G1800891, 74M1701769, 74G1801166

Where was it sold?

ME,NC, WA, MO, NJ, FL, CAL, TX, OH, IL, MA, GA, FL, GA, Canada

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 82307

This product is part of a recall event; the main page for the event is RuSCH One piece Male External Regular Catheter W/O Tape recalled.

Reported	Class	Recall	Company	Reason	Where
22 Jan 2020	CLASS III	RuSCH One piece Male External Regular Catheter W/O Tape recalled	Teleflex Medical	Sterility	11 states

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