Class 2 Device Recall HARVEST(R) TERUMOBCT, BMAC3007 Bone Marrow Procedure Pack

• Date Initiated by Firm: October 20, 2017
• Create Date: November 16, 2017
• Recall Status: Terminated on August 21, 2020
• Recall Number: Z-0104-2018
• Recall Event ID: 78307
• 510(K)Number: K103340 K052925 K991430
• Product Classification: Centrifuges (micro, ultra, refrigerated) for clinical use - Product Code JQC
• Product: HARVEST(R) TERUMOBCT, BMAC2-120-01Bone Marrow Procedure Pack, REF 51423, Rx Only, STERILE EO
• Code Information: UDI Case: 35020583514233, 51423 Each: 05020583514232, Lot 04A9939
• Recalling Firm/ Manufacturer: Terumo BCT, Inc.; 10811 W Collins Ave; Lakewood CO 80215-4440
• Manufacturer Reason for Recall: The patient labels included in the BMAC system procedure packs, catalog numbers 51416 and 51423, are printed with an incorrect lot number, catalog number, and expiry date; the lot number on the procedure pack box label is correct. The expiration noted was not beyond initiation date of the recall. Since the product is noted as sterile, the clearance for K103340, K052925 and K991430 raises question if product was cleared with a sterility claim. Further post-market follow-up will be required to assess the safety risk of the product.
• FDA Determined Cause: Process control
• Action: The firm initiated their recall by letter on 10/20/2017. The letter stated the following: "ACTIONS REQUIRED FOR HEALTHCARE PROVIDERS AND DISTRIBUTORS 1. For product shelved in the original procedure pack (white box), examine the label for catalog/lot numbers as shown in Figure C above. 2. If affected product is in your inventory, contact the Terumo BCT Customer Support Center at +1.877.3.FYI.BCT (U.S. Toll-Free +1.877.339.4228) or +1.303.231.HELP (+1.303.231.4357), Terumo BCT Europe N.V. at +32.2.715.0590, or your local Terumo BCT representative, and Terumo BCT will issue a Return Goods Authorization for product return. 3. Continue to use your unaffected product in accordance with the instructions for use. 4. Distribute this notification to all Harvest Bone Marrow Aspirate Concentrate (BMAC) System users within your organization. 5. IMPORTANT: Complete the attached acknowledgement and return it by fax or email to Terumo BCT by 27 October 2017. Your return of the acknowledgement is critical so we can confirm that you have received the recall notice.
• Quantity in Commerce: 281 units
• Distribution: CA, Co, MO, NY, PA, TX, VA, WI, Turkey, Austria, Spain
• 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.

• 510(K) Database: 510(K)s with Product Code = JQC and Original Applicant = HARVEST TECHNOLOGIES, CORP.; 510(K)s with Product Code = JQC and Original Applicant = HARVEST TECHNOLOGIES, LLC.