Retiro De Equipo (Recall) de HARVEST(R) TERUMOBCT, BMAC3007 Bone Marrow Procedure Pack

Recall

78307

Class 2

Z-0104-2018

2017-10-20

Open, Classified

United States

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=159144

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.

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.