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Terumo 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
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +18773394228
PRRC Contact: Corrine Lucas
EUDAMED SRN: US-MF-000001069
FDA FEI Number: 1000117351
DUNS Number: —

Catalogue (175)

Page 4 of 4

Device	Model / Reference	Registries	Class	Status
Quantum®	21024	FDA UDI	Class I	Unknown
Trima Accel®	82416	FDA UDI	Class II	Active
Harvest®	51449	FDA UDI	Class II	Unknown
SCD Welding Wafer	3NCC987	FDA UDI	Class II	Active
HARVEST® SmartPrep®	51478	FDA UDI	Class I	Unknown
Harvest®	51474	FDA UDI	Class I	Unknown
COBE® Spectra	70620	FDA UDI	Class II	Active
Trima Accel®	82616	FDA UDI	Class II	Active
HARVEST® SmartPrep®	51495	FDA UDI	Class I	Unknown
Harvest® Bmac®	51421	FDA UDI	Class I	Unknown
Harvest®	51448	FDA UDI	Class II	Unknown
Harvest® Bmac®	51429	FDA UDI	Class II	Unknown
Tscd® Ii	62001	FDA UDI	Class II	Active
HARVEST® AdiPrep®	51433	FDA UDI	Class II	Unknown
Harvest® Bmac®	51425	FDA UDI	Class I	Unknown
Anticoagulant Connection Adapter	11221	EUDAMEDFDA UDI	Class II	Active
Spectra Optia Apheresis System	K172590	FDA 510(k)	U	Active
Spectra Optia Apheresis System	K153601	FDA 510(k)	U	Active
T-Cuff	K162365	FDA 510(k)	Class I	Active
Spectra Optia Apheresis System, Spectra Optia Single-Needle Connector, Spectra Optia System Software	K131744	FDA 510(k)	U	Active
Spectra Optia Apheresis System	K181049	FDA 510(k)	U	Active
Spectra Optia Apheresis System, Spectra Optia Exchange Set (disposable Blood Tubing Set)	K141938	FDA 510(k)	U	Active
Spectra Optia Apheresis System	K183081	FDA 510(k)	U	Active
Spectra Optia Apheresis System, Spectra Optia System Software, Spectra Optia Exchange Disposable Set	K132429	FDA 510(k)	U	Active
Spectra Optia Apheresis System, Spectra Optia Exchange Set (with AC Connection), Spectra Optia AC Connection Adapter	K151368	FDA 510(k)	U	Active

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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