Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
PNEUMOCLEAR Heated High-Flow Tube Set Product Usage: The Heated High-Flow Recalled by WOM World of Medicine AG Due to It is possible that the packaging of the...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact WOM World of Medicine AG directly.
Affected Products
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.
Quantity: 124,180 tube sets
Why Was This Recalled?
It is possible that the packaging of the product can be damaged by the prongs on the tube set.
Where Was This Sold?
Worldwide Distribution - US in the state of California and country of Netherlands
About WOM World of Medicine AG
WOM World of Medicine AG has 3 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report