Varithena Administration Pack Recalled Due to Incorrect Syringe Connector Type
Biocompatibles is recalling 432 Varithena (polidocanol injectable foam) Administration Packs due to incorrect syringe connectors. The packs contain luer lock syringes instead of the required luer slip connection syringes.
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 III recall with no reported illnesses or injuries. This is a defective delivery system component issue without reported patient harm, consistent with Moderate severity classification.
Plain-English summary
Biocompatibles UK, Ltd. is recalling 432 Varithena (polidocanol injectable foam) Administration Packs distributed nationwide in the USA. The recalled packs have lot numbers 34067418 and 34067419, both with March 2026 expiration dates.
The administration packs were packaged with incorrect syringe components. Instead of the required silicone oil-free NormJect 10 mL Luer Solo syringes with a luer slip connection, the packs contain NormJect 10 mL Luer Lock Solo syringes. This component mismatch could affect proper delivery of the medication.
Healthcare providers who have received affected lots should stop using these administration packs immediately. Patients should contact their healthcare provider if they have questions about their Varithena treatment or if they experienced any issues following use of this product.
The recalled product
- Product
- Varithena (polidocanol injectable foam) Administration Pack, Contains: 3 silicone-free syringes, 2 compression pads, 1 Varithena Transfer Unit, 1 manometer tubing, Rx Only, Distributed by Biocompatibles Inc., a BTG International Group company. CN01114.3
- Manufacturer
- Biocompatibles UK, Ltd.
- Hazard
- defective-delivery-system
- component-mismatch
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 (3)
- Lot # 34067418
- Exp. March 2026
- 34067419
Distribution
Distributed nationwide across the United States.
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