Terumo Cardiovascular Procedure Kits containing Pall LG6NS LeukoGuard¿ Leukocyte Reduction Arteri...

FDA Device Recall #Z-1314-2018 — Class II — December 18, 2017

Recall Summary

Recall Number Z-1314-2018
Classification Class II — Moderate risk
Date Initiated December 18, 2017
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Terumo Cardiovascular Systems Corp
Location Ashland, MA
Product Type Devices
Quantity 2677

Product Description

Terumo Cardiovascular Procedure Kits containing Pall LG6NS LeukoGuard¿ Leukocyte Reduction Arterial Blood Filters. The Cardiovascular Procedure Kit containing the Pall LG6NS LeukoGuard¿ Leukocyte Reduction Arterial Blood Filter for Exh¿acorporeal Service is indicated for use only in the exh¿acorporeal circuit for cardiopulmonary bypass procedures for which the user designed it. The product is a sterile, disposable kit, intended for one time use for period up to 6 hours, after which it must be discarded in a manner which is within acceptable laws and practices. The Pall LG6NS LeukoGuard ¿ Leukocy1e Reduction Arterial Blood Filter for Exh¿acorporeal Service is designed to reduce the levels of circulating leucocy1es and exclude microemboli greater than 40 ¿m in size from the perfu sate during exh¿acorporea l circulation. This included gas emboli, fat emboli and aggregates composed of platelets, red blood cells and other debris. The Pall LG6NS LeukoGuard ¿ Leukocyte Reduction Arterial Blood Filter can be included in Cardiovascular Procedure Kits (Convenience Kits). When the Pall LG6NS LeukoGuard¿ Leukocyte Reduction Arterial Blood Filters is included in the Kits, the intended use of the filter remains unaffected.

Reason for Recall

Possible blood leaks through the hydrophobic portion of the Pall LG6NS LeukoGuard Leukocyte Reduction Arterial Blood Filters.

Distribution Pattern

US Distribution to the states of : AL, OH, VA, NC, GA, NY, FL

Lot / Code Information

662143 735568 752561 767041 774364 775404 778816 783025 785629 794402 794411 735568

Other Recalls from Terumo Cardiovascular Systems Corp

Recall # Classification Product Date
Z-0949-2022 Class II Cardiovascular Procedure Kit catalog # 76645 & ... Feb 3, 2022
Z-2550-2018 Class II Tubing Pack Convenience Kit, Product Code 65217... May 12, 2017
Z-2706-2016 Class II Terumo Custom Cardiovascular System Cardiovascu... Jul 25, 2016
Z-2786-2015 Class II Terumo Custom Cardiovascular Procedure Kit Tubi... Aug 24, 2015
Z-2788-2015 Class II Terumo Custom Cardiovascular Procedure Kit X-Co... Aug 24, 2015

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.