STOPCON Disposable Endoscope Valves Set-Single Use Valves Olympus R (Air-Water-/Suction) DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ROAD / EDEN PRAIRIE, MN 55344 / USA Product Code: EN10229.2
Reported: December 30, 2020 Initiated: November 3, 2020 #Z-0641-2021
Product Description
STOPCON Disposable Endoscope Valves Set-Single Use Valves Olympus R (Air-Water-/Suction) DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ROAD / EDEN PRAIRIE, MN 55344 / USA Product Code: EN10229.2
Reason for Recall
Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure
Details
- Recalling Firm
- GA HEALTH COMPANY LIMITED
- Units Affected
- 11,000 units
- Distribution
- US Nationwide distribution including in the states of IL,NY, NJ, WI, MI, MN, WI.
- Location
- Shatin N.T., N/A
Frequently Asked Questions
What product was recalled? ▼
STOPCON Disposable Endoscope Valves Set-Single Use Valves Olympus R (Air-Water-/Suction) DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ROAD / EDEN PRAIRIE, MN 55344 / USA Product Code: EN10229.2. Recalled by GA HEALTH COMPANY LIMITED. Units affected: 11,000 units.
Why was this product recalled? ▼
Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 30, 2020. Severity: Moderate. Recall number: Z-0641-2021.
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