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
Reported: December 18, 2024 Initiated: August 15, 2024 #D-0113-2025
Product Description
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
Reason for Recall
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).
Details
- Recalling Firm
- Biocompatibles UK, Ltd.
- Units Affected
- 432 administration packs
- Distribution
- Nationwide in the USA.
- Location
- Farnham
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Biocompatibles UK, Ltd.. Units affected: 432 administration packs.
Why was this product 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).
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 18, 2024. Severity: Low. Recall number: D-0113-2025.
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