REGULATORY INTELLIGENCE·Recall
Biocompatibles UK's Varithena Recall Highlights Critical Packaging Quality Control for Injectable Foam
Biocompatibles UK, Ltd. initiated a Class III recall (D-0113-2025) for 432 units of its Varithena (polidocanol injectable foam) Administration Packs distributed nationwide in the USA. The issue involved incorrect silicone oil-free NormJect 10 mL Luer Lock Solo syringes being packaged instead of Luer Solo syringes. This recall, initiated August 15, 2024, and terminated February 21, 2025, underscores the critical need for stringent quality control in medical device component packaging.
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