medical Class III Updated 2020-01-22

Teleflex Medical recalls Teleflex MEDICAL RuSCH One piece Male External Medium Cathet

Recalled Product

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

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