Custom Tubing Pack with Bioline Coating UDI code: 00607567208230 Part Number: 709000058 The ...

FDA Device Recall #Z-1769-2017 — Class II — February 16, 2017

Recall Summary

Recall Number Z-1769-2017
Classification Class II — Moderate risk
Date Initiated February 16, 2017
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Datascope Corporation
Location Fairfield, NJ
Product Type Devices
Quantity 21 kits

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.

Distribution Pattern

US Distribution to the state of : CA.

Lot / Code Information

Lot number 3000033848

Other Recalls from Datascope Corporation

Recall # Classification Product Date
Z-0131-2023 Class II LINEAR 7.5Fr. 40cc IAB with Accessories (APA), ... Aug 5, 2022
Z-1687-2022 Class II Insertion Kit for use with SENSATION PLUS 8F. 5... Aug 5, 2022
Z-1686-2022 Class II Sensation Plus 8Fr 50cc Intra-Aortic Balloon Ca... Aug 5, 2022
Z-1685-2022 Class II MEGA 8Fr 50cc Intra-Aortic Balloon Catheter Aug 5, 2022
Z-2839-2020 Class II Datascope Intra-Aortic Ballon Catheters (IABs)-... Jul 27, 2020

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.