Status
Terminated
Drug Enforcement D-0113-2025
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).
Classification
Class III
Report Date
December 18, 2024
Termination Date
February 21, 2025
Product Information
- 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
- Product quantity
- 432 administration packs
- 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).
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the USA.
Location & Firm
- Recalling firm
- Biocompatibles UK, Ltd.
- Address
-
Chapman House, Farnham Business Park; Weydon Lane
United Kingdom - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0113-2025
- Event ID
- 95820
- Recall initiation date
- August 15, 2024
- Center classification date
- December 6, 2024
- Code info
- Lot # 34067418, Exp. March 2026, 34067419, Exp. March 2026
- More code info
- —