Recall Z-0508-2019— WOM World of Medicine AG

Name: FDA recall Z-0508-2019
Creator: U.S. Food and Drug Administration
Published: 2018-10-22

Class II · Terminated

Class II FDA medical device recall by WOM World of Medicine AG, initiated 2018-10-22, terminated 2021-05-06. It names one FDA 510(k) clearance: K170784. 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.. Reason: It is possible that the packaging of the product can be damaged by the prongs on the tube set..

Recalling firm: WOM World of Medicine AG
Classification: Class II
Status: Terminated
Initiated: 2018-10-22
Terminated: 2021-05-06
Firm location: Berlin, N/A, Germany

510(k) clearances named in this recall

1 on FDA's record

K170784 — PNEUMOCLEARW.O.M. World of Medicine GmbH·cleared 2017-05-15

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.