Sheath, Corrugated Rubber, For Non-indwelling Catheter, Non-sterile
Gastroenterology, Urology · 21 CFR 876.5250
Urine collector and accessories; see product code EYT.
Recent MDR events
0 adverse event reports on file
No MDR events on file for this product code.
Event type breakdown
No data available.
Most-reported manufacturers
No data available.
Recalls
3 recall events for this product code
- Teleflex MedicalTerminatedJul 15, 2011
Rusch, Sure Seal Golden Drain, One Piece Urinary Incontinence Device, Teleflex Medical.
The Kit contains Skin-Prep protective wipes that were manufactured by the Triad Group and are being recalled by Smith & Nephew, due to possible bacterial contamination.
Z-2831-2011 · View FDA record ↗ - Teleflex MedicalTerminatedUnknown
Teleflex MEDICAL RuSCH One piece Male External Regular Catheter W/O Tape, REF A1500
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.
Z-0796-2020 · View FDA record ↗ - Teleflex MedicalTerminatedUnknown
Teleflex MEDICAL RuSCH One piece Male External Medium Catheter W/O Tape, REF A1500M
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.
Z-0797-2020 · View FDA record ↗
Registered firms
10 firms currently registered for this product code
Teleflex Medical De Tecate, S. De R.l De C.v.
TECATE Baja California, MX
Acanthus Medical Creations, Llc
Wauconda, IL, US
Suzhou Texnet
Suzhou Jiangsu, CN
Wuhan Sitaili Medical Apparatus Development Co.,ltd
Wuhan Hubei, CN
Jm Medical Co., Ltd.
Liaocheng Shandong, CN
Teleflex Medical Llc
Morrisville, NC, US
Fesun Shanghai Co., Ltd.
shanghai, CN
Rece International Corp.
Miami, FL, US
Novem Medical S. De R.l. De C.v.
TIJUANA Baja California, MX
Optimum Medical
West Yorkshire Leeds, GB
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.