Datascope Corporation: Medical Device Recall in 2017 - (Recall #: Z-1769-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: February 16, 2017

Date Posted: April 19, 2017

Recall Number: Z-1769-2017

Event ID: 76518

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.

Status: Terminated

Product Quantity: 21 kits

Code Information:

Lot number 3000033848

Distribution Pattern:

US Distribution to the state of : CA.

Voluntary or Mandated:

Voluntary: Firm initiated