The HEMASHIELD PLATINUM Woven Double Velour Vascular Graft is a woven double velour polyester gra...

FDA Device Recall #Z-2559-2019 — Class II — August 22, 2019

Recall Summary

Recall Number Z-2559-2019
Classification Class II — Moderate risk
Date Initiated August 22, 2019
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm GETINGE US SALES LLC
Location WAYNE, NJ
Product Type Devices
Quantity 1 unit

Product Description

The HEMASHIELD PLATINUM Woven Double Velour Vascular Graft is a woven double velour polyester graft impregnated with highly purified bovine collagen. The HEMASHIELD PLATINUM Woven Double Velour Vascular Graft is designed to reduce bleeding at implant and thereby eliminates the operative preclotting step, including cumbersome autoclave techniques. The collagen is designed to be gradually resorbed by the patient. The CONCENTRICRIMP pleat and GUIDELINE stripe are also featured. In addition to collagen, the graft also contains glycerol as a softening agent.

Reason for Recall

Based on an internal incident report, Getinge/Intervascular SAS has identified that the one (1) HEMASHIELD GOLD Knitted Microvel Double Velour Vascular Bifurcated Graft product with the diameter size of 16 x 9 mm is likely incorrectly packed inside of the carton which was labeled to contain a HEMASHIELD PLATINUM Woven Double Velour Vascular Graft product with the diameter size of 16 x 8 mm ((REF: M00202166168P0, Lot: 18K31, SN: 1190443415, size 16 x 8 mm).

Distribution Pattern

US state of NJ

Lot / Code Information

Lot Code: 18K31 Serial Number: 1190443415 Part Number: M00202166168P0 UDI Code: 00384401018452

Other Recalls from GETINGE US SALES LLC

Recall # Classification Product Date
Z-0677-2020 Class II Maquet Cardiopulmonary GmbH / Getinge Quadrox-i... Nov 13, 2019
Z-2433-2019 Class II Getinge MCC Flow i Disposable CO2 absorber, use... Jul 22, 2019
Z-2077-2019 Class II PulsioFlex Monitoring System, Part Number: 6882... Jun 5, 2019
Z-1221-2019 Class III Maquet Servo-I Ventilator System -EDI CATHETER ... Mar 20, 2019
Z-0987-2019 Class II Maquet XS Flat Screen Monitor Holder, XS32 SPE,... Jan 8, 2019

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.