Maquet Cardiovascular, LLC: Medical Device Recall in 2019 - (Recall #: Z-1669-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

Maquet Getinge- (1) Material :701067370R01 BO-TOP 38803 OPEN HEART PACK W (2) Material: 701067370R02 BO-TOP 38803 OPEN HEART PACK W (3) Material: 701067370R03 BO-TOP 38803 OPEN HEART PACK W

Product Classification:

Class II

Date Initiated: April 18, 2019

Date Posted: June 5, 2019

Recall Number: Z-1669-2019

Event ID: 82703

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

Status: Terminated

Product Quantity: N/A

Code Information:

Batch Numbers: (1) 3000042627 (2) 3000047034 (3) 3000058143

Distribution Pattern:

Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated