Teleflex MEDICAL RuSCH One piece Male External Regular Catheter W/O Tape, REF A1500
Reported: January 22, 2020 Initiated: February 27, 2019 #Z-0796-2020
Product Description
Teleflex MEDICAL RuSCH One piece Male External Regular Catheter W/O Tape, REF A1500
Reason for Recall
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.
Details
- Recalling Firm
- Teleflex Medical
- Units Affected
- 39456 devices
- Distribution
- ME,NC, WA, MO, NJ, FL, CAL, TX, OH, IL, MA, GA, FL, GA, Canada
- Location
- Morrisville, NC
Frequently Asked Questions
What product was recalled? ▼
Teleflex MEDICAL RuSCH One piece Male External Regular Catheter W/O Tape, REF A1500. Recalled by Teleflex Medical. Units affected: 39456 devices.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 22, 2020. Severity: Low. Recall number: Z-0796-2020.
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