Product Wiki · Recalls · U.S. FDA — Device Enforcement

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 therapeuti — recall Z-0508-2019

U.S. FDA — Device Enforcement · Germany · 2018-10-22 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0508-2019
Date of alert: 2018-10-22
Country / jurisdiction: Germany
Risk level: Class II
Risk type: recall
Brand: WOM World of Medicine AG
Product category: device
Product type: Devices

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

Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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