medical Class III Updated 2020-01-22

Teleflex Medical recalls Teleflex MEDICAL RuSCH One piece Male External Regular Cathe

Recalled Product

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

Hazard / Issue

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.

Issued by

FDA

Affected States: ME, NC, WA, MO, NJ, FL, TX, OH, IL, MA, GA
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
View official government recall

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