Recall Z-0797-2020— Teleflex Medical
Class III · Terminated
Class III FDA medical device recall by Teleflex Medical, initiated 2019-02-27, terminated 2023-09-06. FDA's recall record names no specific 510(k) clearance for this event. Product: Teleflex MEDICAL RuSCH One piece Male External Medium Catheter W/O Tape, REF A1500M. 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..
- Recalling firm
- Teleflex Medical
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2019-02-27
- Terminated
- 2023-09-06
- Firm location
- Morrisville, NC, United States
Product description
Teleflex MEDICAL RuSCH One piece Male External Medium Catheter W/O Tape, REF A1500M
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.