Teleflex Medical recalls one-piece male external catheters with incorrect sterile labeling. The device is not meant to be sterile in normal use, but the label claims it is. Consumers should check product details and contact Teleflex for guidance.
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 the product is sterile. This is dangerous because medical devices for incontinence management are not meant to be sterile in normal use, and using a non-sterile product could lead to infections.
The device label incorrectly states it is sterile, but in normal use, the catheter is not expected to be sterile. Using a non-sterile product could increase infection risk, especially for individuals with compromised immune systems or open wounds.
People using Teleflex MEDICAL RuSCH One piece Male External Medium Catheter W/O Tape (REF A1500M) for male incontinence management. Those with specific lot numbers are most at risk.
Check for the product name 'Teleflex MEDICAL RuSCH One piece Male External Medium Catheter W/O Tape' with lot numbers listed in the recall: 74A1800577, 74G1802121, 74A1801939, and others. The product was sold with GTIN 24026704549843.
Look for the product name and lot numbers listed in the recall to confirm if your item is affected.
The device is not meant to be sterile in normal use, but the label incorrectly states it is. Using it as intended should not cause harm, but infection risk may increase.
Check the lot number against the list provided in the recall. If affected, contact Teleflex Medical for guidance.
The device label incorrectly states it is sterile, but in normal use, the catheter is not expected to be sterile.
We’ve drafted a message you can send Teleflex Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0797-2020 — Teleflex Medical Teleflex Medical Hello, I own a Teleflex Medical that is covered by recall Z-0797-2020 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.
