Getinge MCC Flow i Disposable CO2 absorber, used in anesthesia systems.

FDA Device Recall #Z-2433-2019 — Class II — July 22, 2019

Recall Summary

Recall Number Z-2433-2019
Classification Class II — Moderate risk
Date Initiated July 22, 2019
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm GETINGE US SALES LLC
Location WAYNE, NJ
Product Type Devices
Quantity 1444 boxes worldwide

Product Description

Getinge MCC Flow i Disposable CO2 absorber, used in anesthesia systems.

Reason for Recall

Reversed expiration and manufacturing date on the label

Distribution Pattern

US nationwide distribution.

Lot / Code Information

Lot # 1810, 1811 Part Number: 6677845 for 12 pcs, 6673717 for 1 pcs UDI Code: 17325710001988

Other Recalls from GETINGE US SALES LLC

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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.