WOM World of Medicine AG recalls PNEUMOCLEAR Heated High-Flow Tube Set Product Usage: The Heated High-Flow Tube Set is a single use sterile tube set

Recalled December 5, 2018 · FDA recall Z-0508-2019 · WOM World of Medicine AG

Hazard

It is possible that the packaging of the product can be damaged by the prongs on the tube set. · FDA Class II

Units

124,180 tube sets

Sold at

Worldwide Distribution - US in the state of California and country of Netherlands

Description

It is possible that the packaging of the product can be damaged by the prongs on the tube set.

Product

PNEUMOCLEAR Heated High-Flow Tube Set Product Usage: The Heated High-Flow Tube Set is a single use sterile tube set used in combination with the PNEUMOCLEAR C02 insufflator as a separate accessory. The device PNEUMOCLEAR is a C02 insufflator intended for use during diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with gas. The Standard, High Flow/Bariatric, Pediatric and Advanced Flow operating mode of the device are indicated to fill and distend a peritoneal cavity with gas during a laparoscopic procedure. The Pediatric operating mode is indicated for pediatric laparoscopic procedures. The Vessel Harvest operating mode is indicated for use during endoscopic vessel harvesting procedures to create a cavity along the saphenous vein or radial artery. The TAMIS operating mode is indicated to fill and distend the rectum and colon using C02 gas during trans anal minimal invasive surgery.

Manufacturer(s)

WOM World of Medicine AG

Made in

Germany

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →