5/10 Weck¿ Vista" Universal Balloon Open Access Port - Standard Length (70mm), 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: 405912RC, Lot Numbers: 01G1200244, 01M1200020, 01M1200068, 01A1300546, and 01A1300559.

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