United StatesThe Orca Sterile Single Use Air/Water and Suction Valves (Material Number UPN-617-50; GTIN 00840253111012; Lot 38400303; Exp. January 20, 2029) used to control the air/water function on endoscopes during GI procedures are being recalled by Boston Scientific. The firm is removing these devices due to a higher-than-anticipated occurrence of the suction button sticking; 9,750 units were distributed nationwide in the United States.
What's being recalled
Orca Single Use Air/Water and Suction Valves, Material Number (UPN) SUV-617-50; The Orca Air/Water Valve is intended to be used to control the air/water function on an endoscope during a GI (gastrointestinal) endoscopic procedure.
Recalling firm: Boston Scientific Corporation, Marlborough, MA, United States.
How to identify it
GTIN 00840253111012, Lot 38400303, Exp. January 20, 2029
The hazard
Boston Scientific is initiating a medical device removal of Orca Sterile, Single Use Air/Water and Suction Valves due to a higher than anticipated occurrence of the suction button sticking.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US Nationwide distribution.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)
Canada