Maquet Cardiovascular Us Sales, Llc: Medical Device Recall in 2016 - (Recall #: Z-1372-2016)

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:

HLS Set Advanced with BIOLINE Coating Custom tubing packs for the oxygenator

Product Classification:

Class II

Date Initiated: February 23, 2016

Date Posted: April 20, 2016

Recall Number: Z-1372-2016

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:

HLS Set Advanced: Small Adult 5.0 with BIOLINE Coating BEQ-HLS 5050, 70105.2797, Adult 7.0 with BIOLINE Coating BEQ-HLS 7050, 70105.2794 and Adult 7.0 with SOFTLINE Coating BO-HLS 7050, 70105.2786

Distribution Pattern:

US Nationwide Distribution.

Voluntary or Mandated:

Voluntary: Firm initiated