Terumo BCT, Ltd
Lakewood, CO, US
TERUMO BCT, LTD appears in FDA device records in Lakewood, CO. FDA records list 13 510(k) clearances between and , 2 PMA records and 2 registered establishments. As of , FDA records show 11 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
4 namesFDA records resolved to Terumo BCT, Ltd carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Caridian BCT, Incorporatedrecall
- Caridianbct, Inc..510(k), recall
- Gambro Bct, Inc.510(k), PMA, recall
- Harvest Technologies, LLC510(k), enforcement report, recall
510(k) clearance history
FDA records hold 13 510(k) clearances for Terumo BCT, Ltd between 1999 and 2015. The busiest year on record is 1999, with 2. The most recent is 2015, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1999 | 2 |
| 2000 | 1 |
| 2001 | 1 |
| 2002 | 1 |
| 2005 | 1 |
| 2006 | 1 |
| 2007 | 1 |
| 2010 | 2 |
| 2012 | 2 |
| 2015 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K151368 | Spectra Optia Apheresis System, Spectra Optia Exchange Set (with AC Connection), Spectra Optia AC Connection Adapter | LKN | Substantially Equivalent | |
| K121005 | ADIPREP ADIPOSE TRANSFER SYSTEM | MUU | Substantially Equivalent | |
| K113480 | SPECTRA OPTIA APHERESIS SYSTEM | LKN | Substantially Equivalent | |
| K103340 | SMARTPREP2 BMAC SYSTEM, SMARTPREP PLATELET CONCENTRATION SYSTEM | JQC | Substantially Equivalent | |
| K103090 | SPECTRA OPTIA R APHERESIS SYSTEM | LKN | Substantially Equivalent | |
| K071079 | SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET, MODEL 61000, 10200 | LKN | Substantially Equivalent | |
| K052925 | SMARTPREP2 CENTRIFUGE SYSTEM | JQC | Substantially Equivalent | |
| K043261 | HARVEST GRAFT DELIVERY SYRINGE | FMF | Substantially Equivalent | |
| K020252 | SMARTJET GRAFTING LIQUID APPLICATOR, MODELS SK/S & LK/2 | FMF | Substantially Equivalent | |
| K011032 | SMARTJET BONE GRAFT LIQUID APPLICATOR (SPRAY TIP), MODEL SK/S, SMARTJET BONE GRAFT LIQUID APPLICATOR (DUAL LUMEN CANNULA | LYC | Substantially Equivalent | |
| K000456 | HARVEST TECHNOLOGIES DUAL LIQUID APPLICATOR, MODEL SK/S: HARVEST DUAL LIQUID APPLICATOR LK/2 | FMF | Substantially Equivalent | |
| K991430 | SMARTPREP CENTRIFUGE SYSTEM | JQC | Substantially Equivalent | |
| K983022 | SMARTCELL PROCESSING SYSTEM | CAC | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3001980567 | 3002545766 | TERUMO BCT, LTD | OLD BELFAST ROAD, MILLBROOK, LARNE Antrim and Newtownabbey BT40 2SH GB | 2026 | |
| 1722028 | 1000117351 | Terumo BCT, Inc.. | 10811 W COLLINS AVE, Lakewood, CO 80215 US | 2026 | and 2 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- CACApparatus, Autotransfusion
- MCNBarrier, Absorbable, Adhesion
- MMHBlood Establishment Computer Software And Accessories
- LYCBone Grafting Material, Synthetic
- JQCCentrifuges (Micro, Ultra, Refrigerated) For Clinical Use
- KSRContainer, Empty, For Collection & Processing Of Blood & Blood Components
- KSDDevice, Heat-Sealing
- KZLDevice, Warming. Blood And Plasma
- OUGMedical Device Data System
- LKNSeparator, Automated, Blood Cell And Plasma, Therapeutic
- GKTSeparator, Automated, Blood Cell, Diagnostic
- MYYSeparator, Semi-Automated, Blood Component
- KSBSet, Transfer (Blood/Plasma)
- KSSSupplies, Blood-Bank
- FMFSyringe, Piston
- KSWSystem, Processing For Frozen Blood
- MUUSystem, Suction, Lipoplasty
- KCYTourniquet, Pneumatic
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0075-2018 | HARVEST TERUMOBCT, GCP-10 Graft Delivery Pack, REF 51449, Rx Only, STERILE EO Harvest Graph Delivery System is a disposable pack that takes the cell concentrate created while using the BMAC Procedure Packs and allows for hydration of bone graft material for application to the sites doctors deem necessary | Certain lots of the Harvest Graft Delivery System GDP-10 Procedure Packs may have a lack of a seal on the inner pouch. | Class II | Terminated | |
| Z-0104-2018 | HARVEST(R) TERUMOBCT, BMAC2-120-01Bone Marrow Procedure Pack, REF 51423, Rx Only, STERILE EO | 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. | Class II | Terminated | |
| Z-0103-2018 | HARVEST(R) TERUMOBCT, BMAC-30-07 Bone Marrow Procedure Pack, Private Practice / Clinical Use Only, REF 51416, Rx Only, STERILE EO | 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. | Class II | Terminated | |
| Z-0674-2017 | Adiprep Adipose Transfer System. Product Codes: 51431; 51432; 51433; 514001-347. | 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. | Class II | Terminated | |
| Z-0022-2014 | Harvest Graft Delivery System; Model Number: GDP-10 Product Usage: The Harvest Graft Delivery System is intended for the aspiration of bone marrow, autologous blood, plasma, or other body fluids. The system is indicated for die delivery of allograft, autograft, or synthetic bone graft materials to an orthopedic surgical site. In addition, it is designed to facilitate pre-mixing of bone graft materials with the aspirate(s), I.V. fluids, blood, plasma, platelet rich plasma, bone marrow or other specific blood component(s) as deemed necessary by the clinical use requirements. | Potential for leur connector to leak or have cracks. | Class II | Terminated | |
| Z-1683-2012 | Terumo BCT Lakewood, CO 80215, Catalog No 61000 Spectra Optia Apheresis System, Country of Origin: US. Product Usage: For use in humans. Within the US marketplace, this device is approved for use in Therapeutic Plasma Exchange. Internationally, this device is approved for use in Mono Nucleo Cell engraftment. | Defective product may result in decreased efficacy. | Terminated | ||
| Z-1504-2012 | Caridian BCT COBE Spectra System Blood Warmer, Catalog number 950000000. | Potential for air entry into the fluid pathway of the COBE Spectra due to a leak at the return luer connection to an elevated bloodwarmer when directions for use are not followed. | Terminated | ||
| Z-0191-2012 | Spectra Optia Apheresis System, REF: 61000, Caridian BCT, Lakewood, CO 80215. A blood component separator used for therapeutic plasma exchanges. | Possible higher than expected platelet loss following therapeutic plasma exchange or plasmapheresis. | Terminated | ||
| Z-2674-2011 | Spectra Optia Apheresis System, REF: 61000, CaridianBCT, Lakewood, CO 80215. The Spectra Optia Apheresis System, a blood component separator, is intended for use in therapeutic apheresis applications. The system may be used to perform Therapeutic Plasma Exchange, Mononuclear Cell Collection, and Red Blood Cell Exchange. | An additional air detection system is being added to all existing systems to detect air in the system's return line. | Terminated | ||
| Z-1541-2012 | Trima Accel Automated Blood Collection System, catalog number 917000000, Caridian BCT, Lakewood, CO 80215 USA. Product Usage: Automated Blood Collection System for use in humans. | Labeling clarification and software updates to include fixes for end of run summaries, increasing boot reliability, corrections to the double red blood cell count collection TBV limit, and to be in compliance with the most current FDA guidance for post donation platelet count targets. | Terminated | ||
| Z-0078-2008 | Spectra Optia apheresis system, a blood component separator. Part No. 61000, Gambro BCT Lakewood, CO USA 80215. | Under specific conditions, apheresis machine could return up to 60mL of air to the patient. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain