FDA-Drug2024-12-18Class III
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
Biocompatibles UK, Ltd.
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).
Sold states
Nationwide in the USA.
Affected count
432 administration packs
Manufactured in
Chapman House, Farnham Business Park; Weydon Lane, Farnham, United Kingdom
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0113-2025Don't want to check this manually?
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