Boston Scientific Orca Single Use Air/Water and Suction Valves recalled for suction button sticking
Boston Scientific is removing Orca Sterile Single Use Air/Water and Suction Valves from distribution because the suction button is sticking more often than expected. These valves are used during gastrointestinal endoscopic procedures to control air and water flow on endoscopes. No injuries have been reported.
From the FDA notice · Read the official notice ↗ · All Boston Scientific recalls
What to do
- If you have Orca valves (Material Number SUV-617-50, Lot 38400303, Exp. January 20, 2029), stop using them and contact Boston Scientific.
- Do not use affected units in any endoscopic procedures.
- Return or quarantine the affected valves according to your facility's procedures.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- 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.
- Sold in
- Nationwide
- Made for
- All ages (0 months and older)
Details
- Units affected
- 9750 units
- Illnesses reported
- None reported
- Manufactured in
- 100 Boston Scientific Way, N/A, Marlborough, MA, United States
- Classification
- Class II
- Recall number
- Z-2413-2026
In the FDA's words
- Description
- 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. 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. GTIN 00840253111012, Lot 38400303, Exp. January 20, 2029 Distribution: US Nationwide distribution. Affected quantity: 9750 units
- 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.
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