Teleflex Medical recalls one piece male external catheters with incorrect sterile labeling. The device is not meant to be sterile in normal use for incontinence management.
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.
Teleflex Medical is recalling male external catheters that incorrectly state they are sterile. This is a labeling error because the catheter isn't meant to be sterile in normal use for incontinence care.
The catheter label incorrectly states it is sterile, but it's designed for non-sterile use in normal incontinence care. This labeling error doesn't pose a direct health risk since the catheter isn't meant to be sterile.
Men who use this catheter for incontinence management are affected. Those with medical conditions requiring catheter use are most at risk.
Check for the model 'Teleflex MEDICAL RuSCH One piece Male External Regular Catheter W/O Tape, REF A1500'. Lot numbers include 74A1800914 through 74L1700304.
Look for the model number and lot numbers listed in the recall notice.
Yes, the catheter is safe for use as intended, but the label incorrectly states it is sterile.
The device label incorrectly states it is sterile, but it's not expected to be sterile in normal use.
Check the label for the model and lot numbers; if it matches, contact Teleflex Medical for guidance.
We’ve drafted a message you can send Teleflex Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0796-2020 — Teleflex Medical Teleflex Medical Hello, I own a Teleflex Medical that is covered by recall Z-0796-2020 from Teleflex Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
