Amicus MNC Apheresis Kit - Double Needle - Product Usage: intended for use in the collection of b...

FDA Device Recall #Z-1343-2021 — Class II — February 25, 2021

Recall Summary

Recall Number Z-1343-2021
Classification Class II — Moderate risk
Date Initiated February 25, 2021
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Fenwal Inc
Location Lake Zurich, IL
Product Type Devices
Quantity 4488 units

Product Description

Amicus MNC Apheresis Kit - Double Needle - Product Usage: intended for use in the collection of blood components and mononuclear cells.

Reason for Recall

Some lots of Amicus MNC Apheresis and Amicus Exchange kits have leaking centrifuge packs during a procedure on the Amicus Separator using therapeutic protocols only. The defect is a blood leak at the boot, elbow, or in the channel on the separation chamber of the centrifuge pack.

Distribution Pattern

US Nationwide distribution in the states of GA, TX, TN, MD, CA, KS, MN, MA, NM, NC, LA, CO, KY, NV, PA, UT, MI, NJ, IL, MD, OH, NY, FL.

Lot / Code Information

Product Code X6R2326; UDI: 04086000100144; Batch Numbers FA20E25234 ((Exp. 05/31/2022), FA20F23120 (Exp. 06/30/2022), FA20I21268 (Exp. 09/30/2022), and FA20J19246 (Exp. 10/31/2022).

Other Recalls from Fenwal Inc

Recall # Classification Product Date
Z-1255-2023 Class II Amicus Exchange Kit Therapeutics. Component of ... Feb 14, 2023
Z-1254-2023 Class II Amicus MNC Apheresis Kit Double Needle. Compo... Feb 14, 2023
Z-1344-2021 Class II Amicus Exchange Kit - Product Usage: intended f... Feb 25, 2021
Z-1345-2021 Class II Amicus Exchange Kit Therapeutics - Product Usag... Feb 25, 2021
Z-2065-2019 Class I Vigilant Agilia, Vigilant Drug'Lib, REF Z073476... Jun 24, 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.