Biocompatibles UK, Ltd. recalls Varithena (polidocanol injectable foam) Administration Pack, Contains: 3 silicone-free syringes, 2 compression pads, 1 V
Recalled December 18, 2024 · FDA recall D-0113-2025 · Biocompatibles UK
Hazard
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). · FDA Class III
Units
432 administration packs
Sold at
Nationwide in the USA.
Description
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).
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(s)
Biocompatibles UK, Ltd.
Made in
United Kingdom
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →