Recall Z-1769-2017— Datascope Corporation

Name: FDA recall Z-1769-2017
Creator: U.S. Food and Drug Administration
Published: 2017-02-16

Class II · Terminated

Class II FDA medical device recall by Datascope Corporation, initiated 2017-02-16, terminated 2019-03-21. It names one FDA 510(k) clearance: K080592. Product: Custom Tubing Pack with Bioline Coating UDI code: 00607567208230 Part Number: 709000058 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 heart-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. The Bioline Coating improves the physical surface properties of products for the extracorporeal circulation system.. Reason: A complaint was received on January 1, 2017 stating the pigtail on line 2 of the oxygenator was assembled to the port where the yellow cap and the clear cap remained on the center port..

Recalling firm: Datascope Corporation
Classification: Class II
Status: Terminated
Initiated: 2017-02-16
Terminated: 2019-03-21
Firm location: Fairfield, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K080592 — HLM TUBING SET WITH BIOLINE COATINGMaquet Cardiopulmonary, AG·cleared 2008-09-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Custom Tubing Pack with Bioline Coating UDI code: 00607567208230 Part Number: 709000058 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 heart-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. The Bioline Coating improves the physical surface properties of products for the extracorporeal circulation system.

Reason for recall

A complaint was received on January 1, 2017 stating the pigtail on line 2 of the oxygenator was assembled to the port where the yellow cap and the clear cap remained on the center port.

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