Biocompatibles UK, Ltd. is recalling 432 Varithena (polidocanol injectable foam) Administration Packs because they contain the wrong type of syringe. The packs were packaged with 10 mL Luer Lock syringes instead of the required 10 mL Luer Solo slip-connection syringes. The affected packs are labeled with item number CN01114.3 and were distributed nationwide to healthcare facilities.
The use of an incorrect syringe connection type (luer lock instead of luer slip) may prevent the healthcare provider from properly connecting the syringe to the administration system, potentially delaying or complicating the treatment of the patient. No injuries or incidents have been reported at the time of this recall.
Pack contains: 3 silicone-free syringes, 2 compression pads, 1 Varithena Transfer Unit, and 1 manometer tubing.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.