Datascope Corporation: Medical Device Recall in 2016 - (Recall #: Z-2002-2016)

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:

Small Patient ECC Pack, REF BEQ-TOP 24100, Product Usage: The HLM Tubing Sets with Bioline Coating are for single use only. They may be sold sterile, non-sterile and bulk packed. Custom tubing sets that are sold sterile are not to be re-sterilized by the user. In open heart surgery the HLM Tubing Sets with Bioline Coating are used in combination with the heart-lung machine for the oxygenation of blood and removal of carbon dioxide. The main purpose of the HLM Tubing Sets with Bioline Coating is to connect the patient to the hear-lung machine and its components. The HLM Tubing Sets with Bioline Coating are therefore a component in the extracorporeal perfusion circulation system. The utilization period of the use of the tubing sets is restricted to six hours

Product Classification:

Class II

Date Initiated: May 9, 2016

Date Posted: June 22, 2016

Recall Number: Z-2002-2016

Event ID: 74341

Reason for Recall:

Custom Tubing Set BEQ-TOP-24100 (Small Patient ECC Pack) was identified as possessing a level of endotoxin that exceeded the regulatory limits.

Status: Terminated

Product Quantity: 17 units

Code Information:

Lot/batch No: 3000003260, Part number 701050175

Distribution Pattern:

US in the state of GA

Voluntary or Mandated:

Voluntary: Firm initiated