Recall Z-1508-2019— Maquet Cardiovascular, LLC

Name: FDA recall Z-1508-2019
Creator: U.S. Food and Drug Administration
Published: 2019-04-18

Class II · Terminated

Class II FDA medical device recall by Maquet Cardiovascular, LLC, initiated 2019-04-18, terminated 2025-07-28. It names one FDA 510(k) clearance: K080592. Product: Maquet Getinge-BEQ-TOP 24500 ADULT ECC Material: 701050253. Reason: 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.

Recalling firm: Maquet Cardiovascular, LLC
Classification: Class II
Status: Terminated
Initiated: 2019-04-18
Terminated: 2025-07-28
Firm location: Wayne, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K080592 — HLM TUBING SET WITH BIOLINE COATINGMaquet Cardiopulmonary, AG·cleared 2008-09-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Maquet Getinge-BEQ-TOP 24500 ADULT ECC Material: 701050253

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.