Terumo BCT, Ltd.

2017

• 20 Oct 2017 Z-0075-2018 Class II Terminated Certain lots of the Harvest Graft Delivery System GDP-10 Procedure Packs may have a lack of a seal on the inner pouch.via FDA establishment Terumo BCT, Inc..
• 20 Oct 2017 Z-0103-2018 Class II Terminated 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.via FDA establishment Terumo BCT, Inc..
• 20 Oct 2017 Z-0104-2018 Class II Terminated 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.via FDA establishment Terumo BCT, Inc..

2016

• 3 Nov 2016 Z-0674-2017 Class II Terminated Terumo BCT announces a voluntary field action for the Harvest : Adiprep Adipose Transfer System because the affected product is incorrectly labeled and has the potential for operator confusion.via FDA establishment Terumo BCT, Inc..