Reported Aug 9, 2023 · Ongoing
Gore Tips Set Device, Catalog Number TSET1016, percutaneous liver access
Creganna Medical Devices
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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: Creganna Medical Devices · Parkmore House · Galway, N/A · N/A
Is this the product you have?
- Gore Tips Set Device, Catalog Number TSET1016, percutaneous liver access
- Lot codes and dates
- UDI/DI 05391526210000
- Lot Numbers
1V000996351V001669281V00199622
- Amount recalled
- 194 units
Where it was sold
- Nationwide
- AZ
Why it was recalled
Three lots of product may be labeled with an incorrect expiration day
This product could cause temporary or reversible health problems — stop using it.
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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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