Food, drugs, devices › Teleflex Medical
Device recall: Teleflex MEDICAL RuSCH One piece Male External Regular Catheter W/O Tape, REF A1500
FDA enforcement event 82307 is a device recall by Teleflex Medical of Morrisville, NC, initiated 27 Feb 2019 and classified Class III, with 2 product records.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 6% of the 968 device enforcement events initiated in 2019 carry the same class.
Status: Terminated, terminated 6 Sep 2023. Initiation: voluntary: firm initiated. Teleflex Medical has 82 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Teleflex Medical, Morrisville, NC.
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."
Distribution
"ME,NC, WA, MO, NJ, FL, CAL, TX, OH, IL, MA, GA, FL, GA, Canada"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0796-2020 | Teleflex MEDICAL RuSCH One piece Male External Regular Catheter W/O Tape, REF A1500 | 39456 devices | Class III | Terminated | 22 Jan 2020 |
| Z-0797-2020 | Teleflex MEDICAL RuSCH One piece Male External Medium Catheter W/O Tape, REF A1500M | 13104 devices | Class III | Terminated | 22 Jan 2020 |
Context
Other enforcement events for Teleflex Medical
All 82 events for Teleflex Medical
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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."
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "ME,NC, WA, MO, NJ, FL, CAL, TX, OH, IL, MA, GA, FL, GA, Canada"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 6 Sep 2023. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.