Recall Z-2002-2016— Datascope Corporation

Class II FDA medical device recall by Datascope Corporation, initiated 2016-05-09, terminated 2017-03-28. FDA's recall record names no specific 510(k) clearance for this event. Product: 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. Reason: Custom Tubing Set BEQ-TOP-24100 (Small Patient ECC Pack) was identified as possessing a level of endotoxin that exceeded the regulatory limits..

Recalling firm

Datascope Corporation

Classification

Class II

Status

Terminated

Initiated

2016-05-09

Terminated

2017-03-28

Firm location

Fairfield, NJ, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.