Reported Dec 5, 2018 · Terminated
PNEUMOCLEAR Heated High-Flow Tube Set Product Usage: The Heated High-Flow Tube Set is a single use sterile tube set…
WOM World of Medicine AG
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: WOM World of Medicine AG · Salzufer 8 · Berlin, N/A · N/A
Is this the product you have?
- PNEUMOCLEAR
- Heated High-Flow Tube Set Product UsageThe 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
- Lot codes and dates
- Lots from 4011926 to 4013513 (ALL)
- Amount recalled
- 124,180 tube sets
Where it was sold
Why it was recalled
It is possible that the packaging of the product can be damaged by the prongs on the tube set.
This product could cause temporary or reversible health problems — stop using it.
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