Teleflex Medical: Teleflex MEDICAL RuSCH One piece Male External Regular Catheter W/O Tape, REF A1500

Is my product affected?

Teleflex MEDICAL RuSCH One piece Male External Regular Catheter W/O Tape, REF A1500

• UPC 24026704549836

Check against the official notice below — it lists the full affected range.

What happened

Teleflex Medical is recalling approximately 39,456 units of the RuSCH One Piece Male External Regular Catheter Without Tape (Reference A1500) distributed across multiple states and Canada. The recall involves product labeling that incorrectly states the device is sterile. This external male condom-type catheter is designed to manage male incontinence, and in normal use, the device is neither expected nor required to be sterile, making the sterile labeling claim inaccurate.

The affected devices are identified by GTIN 24026704549836 and include multiple lot numbers ranging from 74A1800914 through 74L1700304. The recall notice does not specify a remedy or instructions for affected consumers regarding what action they should take.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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.

Details from the source

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. Distribution: ME,NC, WA, MO, NJ, FL, CAL, TX, OH, IL, MA, GA, FL, GA, Canada Quantity: 39456 devices Lot/code info: GTIN 24026704549836 Lot Numbers: 74A1800914, 74A1801938, 74A1802088, 74B1800292, 74B1800362, 74B1801603, 74C1800428, 74C1801090, 74C1801172, 74C1802127, 74E1800684, 74E1802780, 74F1800358, 74F1801409, 74F1801915, 74G1800046, 74G1800893, 74G1801165, 74H1700889, 74H1701630, 74H1702627, 74J1701765, 74J1702485, 74K1700319, 74L1700073, 74L1700304

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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