Class III
Terminated
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
- Company
- Biocompatibles Uk, Ltd.
- Recall Initiated
- August 15, 2024
- Posted
- December 18, 2024
- Recall Number
- D-0113-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 432 administration packs
- Firm Location
- Farnham, United Kingdom
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).
Distribution
Nationwide in the USA.
Lot / Code Info
Lot # 34067418, Exp. March 2026, 34067419, Exp. March 2026
More recalls by Biocompatibles Uk, Ltd.
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