FDAHealthAugust 15, 2024

Biocompatibles UK, Ltd. — Varithena (polidocanol injectable foam) Administration Pack, Contains: 3 silicone-free syringes, 2 compression pads, 1 Varithena Transfer Unit, 1 manometer tubing, Rx Only, D

⚠️ Defective Delivery System: incorrect silicone oil-free NormJect 10 mL Luer Lock Solo syringes packaged in the pack, instead of the required silicone oil-free NormJect 10 mL Luer Solo syringes (luer slip connection).

Is this relevant to me?

Geography: Nationwide
Source agency: FDA
Category: Health
Published: August 15, 2024

Nationwide in the USA.

What's affected?

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
Brand: Biocompatibles UK, Ltd.
Lot code: 34067418

Additional details

Lot # 34067418, Exp. March 2026, 34067419, Exp. March 2026

What should I do?

Recommended action

Class III recall. Voluntary: Firm initiated Quantity affected: 432 administration packs.

View original FDA notice →

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