Alcon Research LLC is recalling 3,486 Alcon Custom-Pak surgical kits because the Anti-Reflux Valve (ARV) in the tubing can break due to improper use. The recall includes various surgical and vitrectomy kits distributed to specific medical facilities. While no injuries have been reported, Alcon has updated the product labeling to address this risk. These kits are used in ophthalmic procedures and were sold to Christiana Care Health Services, Mercy Hospital, Illinois Masonic Medical Center, and McGee Eye Surgery Center.
A broken Anti-Reflux Valve in the surgical tubing can interfere with fluid management during surgery. This could potentially lead to procedural delays or surgical complications if the equipment fails while in use.
Contains Tubing, Salem Sump, 14 FR
Contains Tubing, Salem Sump, 18 FR
Contains Tubing, Salem Sump, 18 FR
Contains Tubing, Salem Sump, 14 FR
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Sources: FDA iRES · Raw API Response
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