FDA recall Z-0641-2021

Product

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

Distribution

US Nationwide distribution including in the states of IL,NY, NJ, WI, MI, MN, WI.

Key facts

Status

Terminated

Initiation date

2020-11-03

Report date

2020-12-30

Termination date

2021-09-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Shatin N.T., N/A, Hong Kong SAR

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0641-2021