Centurion DIFFICULT IV KIT containing BD's Vacutainer Plastic Lithium Heparin Tubes (BD Vacutain...

FDA Device Recall #Z-2545-2020 — Class II — June 1, 2019

Recall Summary

Recall Number Z-2545-2020
Classification Class II — Moderate risk
Date Initiated June 1, 2019
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Centurion Medical Products Corporation
Location Williamston, MI
Product Type Devices
Quantity 140 units

Product Description

Centurion DIFFICULT IV KIT containing BD's Vacutainer Plastic Lithium Heparin Tubes (BD Vacutainer-BD Codes 367884 & 367960; Centurion code 45177 (VACUTAINER GREEN TOP) and 84815 (VACUTAINER 3ML LT. GREEN). Centurion Kit Code: IV8860

Reason for Recall

False elevation of carboxyhemoglobin (COHb) results in blood samples collected using BD Vacutainer¿ Plastic Lithium Heparin tubes with the IL GEM 4000 instrument.

Distribution Pattern

US Nationwide distribution including in the state of IL.

Lot / Code Information

Lot Number: 2019050790 exp. Date: 10/31/2019

Other Recalls from Centurion Medical Products Corporation

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Z-1047-2020 Class II Centurion- Dressing Change Tray DT10290S CENTR... Dec 11, 2019
Z-1091-2020 Class II Centurion- ENT SNUF3 SNUFFER KIT Y Dec 11, 2019
Z-1063-2020 Class II Centurion-LVAD Kits DM1005 DAILY LVAD MAINTENA... Dec 11, 2019
Z-1090-2020 Class II Centurion- Skin Prep Kits SB1280 SKIN SCRUB KI... Dec 11, 2019
Z-1058-2020 Class II Centurion- Umbilical Trays UVT1045 UMBILICAL A... Dec 11, 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.