Gore Tips Set Device Recall: Incorrect Expiration Date Labeling
Creganna Medical Devices is recalling three lots of Gore Tips Set Device due to incorrect expiration date labeling. Affected devices may be used past their actual expiration date.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall for a labeling error with no reported illnesses or injuries. An incorrect expiration date could result in use of an expired device, but this is a precautionary recall with no documented safety incidents.
Plain-English summary
Creganna Medical Devices is recalling three lots of Gore Tips Set Device (Catalog Number TSET1016), a medical device used for percutaneous liver access. The affected lots are labeled with an incorrect expiration day.
An incorrectly labeled expiration date could result in use of a device past its actual safety expiration, potentially leading to device malfunction or ineffectiveness. The three affected lot numbers are 1V00099635, 1V00166928, and 1V00199622.
This recall affects 194 units distributed in Arizona. Physicians, healthcare facilities, and patients should verify whether they have devices from these affected lots.
If you have a device from an affected lot, discontinue use and contact Creganna Medical Devices for return or replacement. The U.S. Food and Drug Administration (FDA) classified this as a Class II recall.
The recalled product
- Product
- Gore Tips Set Device, Catalog Number TSET1016, percutaneous liver access
- Manufacturer
- Creganna Medical Devices
- Affected units
- 194
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- UDI/DI 05391526210000
- Lot Numbers: 1V00099635
- 1V00166928
- 1V00199622
Distribution
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