GORE VIABIL Biliary Endoprosthesis Recalled for Incorrect Labeling
W L Gore & Associates is recalling 13 GORE VIABIL Short Wire Biliary Endoprostheses because they were incorrectly labeled with the wrong model number and dimensions.
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: The recall is classified as FDA Class II, which is typically associated with minor labeling errors or low-risk contamination where the probability of serious adverse health consequences is remote. No injuries or illnesses are reported in the source text.
Plain-English summary
W L Gore & Associates, Inc. is recalling 13 units of the GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1010. The recall is due to a labeling error where devices with a 10 mm diameter and 7 cm length with transmural drainage holes (VSWVH1006) were incorrectly labeled as 10 mm diameter and 10 cm length devices without transmural drainage holes (VSWVN1010).
The affected units were distributed nationwide in the states of Georgia and Rhode Island. The incorrect labeling could lead to the use of the wrong device specification for a patient's specific medical needs.
Healthcare providers and facilities should check their inventory for the specific lot serial numbers and UDI codes listed in the recall notice. If the affected devices are found, they should be removed from use and returned to the manufacturer or disposed of according to the recall instructions.
The recalled product
- Product
- GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1010. Flexible, self-expanding endoprosthesis designed to maintain luminal patency of the common bile duct which may be obstructed.
- Manufacturer
- W L Gore & Associates, Inc.
- Hazard
- Affected units
- 13
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 (15)
- Incorrect Catalogue Number/UDI: VSWVN1010 / 00733132638888
- VSWVN1010 / 00733132638888
- Lot Serial No. 30965053
- 30965054
- 30965055
- 30965056
- 30965057
- 30965058
- 30965059
- 30965060
- 30965061
- 30965062
- 30965063
- 30965064
- 30965065.
Distribution
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