Maquet Cardiovascular, LLC: Medical Device Recall in 2019 - (Recall #: Z-1646-2019)

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: 701053941R01 BEQ-TOP 9005 3/8 Custom Pk w/RF32 & HMOD (2) Material: 701053941R02- BEQ-TOP 9005 3/8 Custom Pk w RF32 & HMOD Material:

Product Classification:

Class II

Date Initiated: April 18, 2019

Date Posted: June 5, 2019

Recall Number: Z-1646-2019

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) 3000051652 3000054808 3000058733 3000062473 3000071201 3000073170 3000075123 (2) 3000076148 3000081600

Distribution Pattern:

Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated