Maquet Cardiovascular Us Sales, Llc: Medical Device Recall in 2016 - (Recall #: Z-1374-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

Custom Tubing Packs Custom tubing pack for oxygenators

Product Classification:

Class II

Date Initiated: February 23, 2016

Date Posted: April 20, 2016

Recall Number: Z-1374-2016

Event ID: 73390

Reason for Recall:

Maquet Cardiopulmonary (MCP) is conducting a voluntary recall based on the potential risk of exposure to endotoxin for various products.

Status: Terminated

Product Quantity: 72,000 units in total

Code Information:

containing products included in this action which include the following serial numbers; T xxxxx, TOP xxxxx, BE-TOP xxxxx, BO-TOP xxxxx, BO-T xxxxx, BEQ-T xxxxx, and BEQ-TOP xxxxx.

Distribution Pattern:

US Nationwide Distribution.

Voluntary or Mandated:

Voluntary: Firm initiated