AngioDynamics Recalls Soft-Vu Angiographic Catheters Due to Mislabeled Pouches
AngioDynamics is recalling one lot of Soft-Vu angiographic catheters because a pouch inside the box may be mislabeled.
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 and involves a minor labeling error (mislabeled pouch) without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
AngioDynamics is recalling one lot of Soft-Vu (JB-1) Non-braided angiographic catheters. The recall is due to a potential labeling error where one of the catheter pouches within the outer box may be mislabeled.
The affected product is the Soft-Vu (JB-1) Non-braided catheter, size 5F, length 100cm, designed to accept a .035 in. guidewire. The specific lot number is 564325, and the catalog number is 10734201. The products were packaged in boxes of 5 catheters each. The total quantity involved is 7 boxes, containing 35 units.
Distribution was worldwide, including the United States (nationwide, with specific mentions of CA, KS, MO, and NC) and the Czech Republic and Switzerland. The intended use for these devices is angiographic diagnosis. Healthcare facilities and distributors should check their inventory for this specific lot and stop using the affected units.
The recalled product
- Product
- AngioDynamics Angiographic catheter --- Soft-Vu (JB-1) Non-braided. --- Size: 5F; Length: 100cm; designed to accept guidewire: .035 in. --- Catalog No. [REF]: 10734201. Packaged in boxes of 5 catheters each, with manufacturer listed as AngioDynamics, Inc., Queensbury, NY USA.
- Manufacturer
- Angiodynamics Worldwide Headquarters
- Hazard
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 (1)
- Lot: 564325
Distribution
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