Reported Jan 22, 2020 · Terminated
Teleflex MEDICAL RuSCH One piece Male External Medium Catheter W/O Tape, REF A1500M
Teleflex Medical
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Teleflex Medical · 3015 Carrington Mill Blvd · Morrisville, NC · 27560-5437
Is this the product you have?
- Teleflex MEDICAL RuSCH One piece Male External Medium Catheter W/O Tape, REF A1500M
- Lot codes and dates
- GTIN 24026704549843 Lot Numbers
74A180057774G180212174A180193974H170089474B180036374J170086474B180160474J170248974B180274674C180117874K170225774L170007474C180129474L170170174C180213274M170012174G180004774M170115074G180089174M170176974G1801166
- GTIN 24026704549843 Lot Numbers
- Amount recalled
- 13104 devices
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was 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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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