Class 2 Device Recall Amicus MNC Apheresis Kit Double Needle

• Date Initiated by Firm: February 25, 2021
• Create Date: April 02, 2021
• Recall Status: Terminated on April 18, 2023
• Recall Number: Z-1343-2021
• Recall Event ID: 87407
• Product Classification: Separator, automated, blood cell, diagnostic - Product Code GKT
• Product: Amicus MNC Apheresis Kit - Double Needle - Product Usage: intended for use in the collection of blood components and mononuclear cells.
• 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).
• Recalling Firm/ Manufacturer: Fenwal Inc; 3 Corporate Dr Ste 300; Lake Zurich IL 60047-8930
• For Additional Information Contact: Matt Kuhn; 847-550-2300
• Manufacturer 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.
• FDA Determined Cause: Under Investigation by firm
• Action: A Recall notification letter titled, "URGENT - Medical Device Recall Amicus MNC Apheresis/Exchange Disposable Kits" and form titled, Amicus Therapeutic Kits Customer Reply Form were sent to consignees on 02/25/2021 via Fed Ex Overnight Express. The consignee requested their customers to: 1) Discontinue use of the affected products immediately by checking their inventory and quarantining all affected product at their facility. They were also informed to contact Fresenius Kabi Customer Service at 800-333-6925, Prompt 1 for replacement kits to ensure additional procedures can continue. 2) Inform potential users of the product in their organization of this notification. 3) Based on the options listed below, complete the attached response form and return via the fax number, email address, or the enclosed Fed Ex envelope and return address. Option A: If there is no remaining inventory of the affected product  complete the response form and return it to Fresenius Kabi. Option B: If the customer has affected product in inventory and wishes to return it: Contact Fresenius Kabi Customer Service at 800-333-6925, Prompt 1 and request to return the affected product. They will assist the customer with placing a replacement order at that time. Option C: If the customer has a small number of kits in inventory and are willing to destroy the product on Fresenius Kabis behalf: Contact Fresenius Kabi Customer Service at 800-333-6925, Prompt 1 to identify if the customer has product to be destroyed and require replacement. They will provide a certificate of destruction for completion. Once completed, the certificate should be returned to Fresenius Kabi and replacements will be sent. Customers may be in a position that no alternate Device is available and therefore choose to continue with the use of the affected Amicus MNC Apheresis kits or Amicus Exchange kits (Therapeutics kits). For such cases, the following actions should be put in place until replacement products a
• Quantity in Commerce: 4488 units
• Distribution: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.