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Sign in to claim this brandTerumo BCT, Inc..
United States·US-MF-000001069
Last updated September 17, 2026
Information
- Country
- United States
- Address
- 10811, W. Collins Ave., Lakewood, United States
- Website
- www.terumobct.com
- —
- —
- [email protected]
- Phone
- +18773394228
- PRRC Contact
- Corrine Lucas
- EUDAMED SRN
- US-MF-000001069
- FDA FEI Number
- 1000117351
- DUNS Number
- —
Catalogue (175)
Page 3 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Quantum® | 21020 | FDA UDI | Class I | Unknown |
| TOMEs TERUMO OPERATIONAL MEDICAL EQUIPMENT SOFTWARE | 11401 | FDA UDI | Class II | Active |
| Trima Accel® | 80370 | FDA UDI | Class II | Unknown |
| HARVEST® SmartPrep® | 51487 | FDA UDI | Class I | Unknown |
| Harvest® | 51407 | FDA UDI | Class II | Unknown |
| COBE® Spectra | 71100 | FDA UDI | Class II | Unknown |
| Cobe® 2991 | 90819 | FDA UDI | Class II | Active |
| Platelet Additive Solution Connection Adapter | 70070 | FDA UDI | Class II | Active |
| Harvest® Bmac® | 51423 | FDA UDI | Class I | Unknown |
| HARVEST® SmartPrep® | 51494 | FDA UDI | Class I | Unknown |
| COBE® Spectra | 70100 | FDA UDI | Class II | Active |
| Harvest® Bmac® | 51417 | FDA UDI | Class II | Unknown |
| HARVEST® SmartPrep® | 51490 | FDA UDI | Class I | Unknown |
| Vista ® | 25203 | FDA UDI | Class II | Active |
| Harvest® | 51414 | FDA UDI | Class II | Unknown |
| Trima Accel® | 80440 | FDA UDI | Class II | Unknown |
| Harvest® Bmac® | 51427 | FDA UDI | Class I | Unknown |
| HARVEST® SmartJet® | 51451 | FDA UDI | Class II | Unknown |
| Trima Accel® | 80500 | FDA UDI | Class II | Active |
| Spectra Optia® | 10220 | EUDAMEDFDA UDI | U | Active |
| Tscd®-Ii | 3NCC947 | FDA UDI | Class II | Active |
| Trima Accel® | 82560 | FDA UDI | Class II | Active |
| Trima Accel® | 82660 | FDA UDI | Class II | Unknown |
| COBE® Spectra | 70700 | FDA UDI | U | Active |
| Imugard | 41950 | FDA UDI | Class II | Active |
| Scd®-Iib | 62002 | FDA UDI | Class II | Active |
| Quantum ® | 21023 | FDA UDI | Class I | Unknown |
| Harvest® | 51493 | FDA UDI | Class I | Unknown |
| Harvest® | 51402 | FDA UDI | Class II | Unknown |
| Harvest® | 51409 | FDA UDI | Class II | Unknown |
| HARVEST® SmartPrep® | 51482 | FDA UDI | Class I | Unknown |
| HARVEST® AdiPrep® | 51434 | FDA UDI | Class II | Unknown |
| HARVEST® SmartPrep® | 51486 | FDA UDI | Class I | Unknown |
| Harvest® | 51403 | FDA UDI | Class II | Unknown |
| Harvest® Bmac® | 51430 | FDA UDI | Class II | Unknown |
| Trima Accel® | 80446 | FDA UDI | Class II | Active |
| Spectra Optia® | 12220 | EUDAMEDFDA UDI | Class II | Active |
| HARVEST® SmartJet® | 51453 | FDA UDI | Class II | Unknown |
| Harvest® | 51405 | FDA UDI | Class II | Unknown |
| Trima Accel® | 80410 | FDA UDI | Class II | Active |
| Harvest® | 51410 | FDA UDI | Class II | Unknown |
| Trima Accel® | 82300 | FDA UDI | Class II | Active |
| Trima Accel® | 777098897 | FDA UDI | Class II | Active |
| Quantum® | 21012 | FDA UDI | Class I | Unknown |
| HARVEST® SmartPrep® | 51470 | FDA UDI | Class I | Unknown |
| Accessory Platelet Storage Sets | 70030 | FDA UDI | Class II | Active |
| Tscd®-Ii | 62003 | FDA UDI | Class II | Active |
| Harvest® | 51447 | FDA UDI | Class II | Unknown |
| Accessory Platelet Bag with Integrated Sampler | 70031 | FDA UDI | Class II | Active |
| Trima Accel® | 81002 | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
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Notified Bodies
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Authorities
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FDA Recalls (4)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Oct 20, 2017 | Z-0075-2018 | — | terminated | Certain lots of the Harvest Graft Delivery System GDP-10 Procedure Packs may have a lack of a seal on the inner pouch. |
| Oct 20, 2017 | Z-0103-2018 | — | 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. |
| Oct 20, 2017 | Z-0104-2018 | — | 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. |
| Nov 3, 2016 | Z-0674-2017 | — | 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. |
FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Terumo Bct, Ltd LARNE Antrim and Newtownabbey · GB FEI 3002545766