WOM World of Medicine AG: Medical Device Recall in 2018 - (Recall #: Z-0508-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: October 22, 2018

Date Posted: December 5, 2018

Recall Number: Z-0508-2019

Event ID: 81480

Reason for Recall:

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

Status: Terminated

Product Quantity: 124,180 tube sets

Code Information:

Lots from 4011926 to 4013513 (ALL)

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated