Reported Dec 18, 2024 · Terminated
Varithena (polidocanol injectable foam) Administration Pack, Contains: 3 silicone-free syringes, 2 compression pads, 1…
Biocompatibles UK, Ltd.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Biocompatibles UK, Ltd. · Chapman House · Farnham · N/A
Is this the product you have?
- Varithena (polidocanol injectable foam) Administration Pack
- Contains
3 silicone-free syringes2 compression pads1 Varithena Transfer Unit1 manometer tubingRx OnlyDistributed by Biocompatibles Inca BTG International Group company. CN01114.3
- Lot codes and dates
Lot # 34067418Exp. March 202634067419Exp. March 2026
- Amount recalled
- 432 administration packs
Where it was sold
- Nationwide
Why it was recalled
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).
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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