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Recall Observatory FDA recall evidence

Device product

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

Z-0796-2020

February 27, 2019

Class III

Product summary

Firm
Teleflex Medical
Event
Event 82307
Status
Terminated
Classification
Class III
Quantity
39456 devices
Official record key
device-enforcement:Z-0796-2020

Official wording

Reason: 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.

Code information: 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

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.