[Recalled] Maquet Getinge- BO-TOP 13901 Rapid Response Universal Pk Material: 701054874R01 — Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, t… | FDA 2019-04-18

Regulators flagged this product in an official safety action. Here is what the notice says and what it means for owners.

Recall details

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

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, LLC

• Maquet Getinge-BEQ-TOP 5502 ECC Pack Material:701051791R01 — Class II
• Maquet Getinge-BEQ-TOP 21502# Med City Childr Material: 701050060 — Class II
• Maquet Getinge-BO-TOP 15200 OR PACK HMO & RF Material:701050647R01 — Class II
• Maquet Getinge-BEQ-TOP 22701 Material: 701050790 — Class II
• Maquet Getinge-BEQ-TOP 41201 ECC 3/8 PUMP PAC Material: 701064867 — Class II
• Vasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3000-W . — 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.