[Recalled] QUADROX-i oxygenators Custom tubing packs for the oxygenator — Maquet Cardiopulmonary (MCP) is conducting a voluntary recall based on the pote… | FDA 2016-02-23

A safety authority has issued a recall or warning for this item. The confirmed facts from the source notice are laid out below.

Recall details

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: Maquet Cardiopulmonary (MCP) is conducting a voluntary recall based on the potential risk of exposure to endotoxin for various products.

This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from Maquet Cardiovascular Us Sales, Llc

• Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229037A Model: VST66DF — Class II
• HLS Set Advanced Model Name: BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Code/Part Number: 70105.2797 - Product Usage: These devices are used with the CARDIOHELP system in order to provide extracorporeal circulation for cardiac support and/or pulmonary support. — Class II
• Maquet Cardiopulmonary (MCP)/Getinge ROTAFLOW Drive, Model Number 701022161. The device is a component of the ROTAFLOW System Console. — Class II
• QUADROX iD HMOD 2030 Diffusion Membrane Oxygenator; QUADROX-i ADULT HMO 70000 / HMO 71000; QUADROX-iD Pediatric HMOD 30000. The QUADROX oxygenators are intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. — Class II
• QUADROX iD HMOD 2030 Diffusion Membrane Oxygenator; QUADROX-i ADULT HMO 70000 / HMO 71000; QUADROX-iD Pediatric HMOD 30000 Product Usage: The QUADROX oxygenators are intended for the use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. Within the specified flow r — Class II
• Yuno Mobile Operating Table - Product Usage: Intended for support and position the patient immediately before, during and after surgical interventions as well as for examination and treatment. Part 143301F0 (US) Part 143301B0 (OUS) — Class II

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.