PNEUMOCLEAR Heated High-Flow Tube Set Product Usage: The Heated… — Class II medical device recall Z-0508-2019
Terminated recall by WOM World of Medicine AG, reported 2018-12-05, distributed in CA. It is possible that the packaging of the product can be damaged by the prongs on the tube set.
| Recall number | Z-0508-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | WOM World of Medicine AG, Berlin, N/A, Germany |
| Recall initiated | 2018-10-22 |
| Classified | 2018-11-27 |
| Reported by FDA | 2018-12-05 |
| Terminated | 2021-05-06 |
| Distributed | CA |
| Countries outside the US | NL |
| Quantity | 124,180 tubes |
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 for recall
It is possible that the packaging of the product can be damaged by the prongs on the tube set.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0508-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.