Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Maquet Getinge-BO-TOP 20700 SMALL PATIENT 3/8 Material: 701050966 Recalled by Maquet Cardiovascular, LLC Due to Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization,...

Date: April 18, 2019
Company: Maquet Cardiovascular, LLC
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Maquet Cardiovascular, LLC directly.

Affected Products

Maquet Getinge-BO-TOP 20700 SMALL PATIENT 3/8 Material: 701050966

Quantity: N/A

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Maquet Cardiovascular, LLC

Maquet Cardiovascular, LLC has 251 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report