5/10 Weck¿ Vista" Universal Balloon Open Access Port - Long Length (100mm), Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.

Reason: Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical procedures.

Code information: Product Code: 410944L, Lot Numbers: 01J1200219, 01K1200067, 01K1200600, 01L1200056, 01L1200354, and 01A1300202.

Distribution pattern: Worldwide Distribution - USA Nationwide including Puerto Rica and the countries of: Australia, Brazil, China, Canada, Malaysia, Korea, Ireland Singapore and Vietnam.