Terumo BCT STERILIZATION SERVICES, Inc.
3 recall(s) on record — most severe on record: Class II.
Activity by year
- Recalls (3)
Devices registered here (1)
- Unit, Filter, MembraneProduct code JRL (opens in a new tab) · Class I · Clinical Chemistry · 21 CFR 862.2050
Recalls & enforcement
- Class IITerminated2017-10-20Certain lots of the Harvest Graft Delivery System GDP-10 Procedure Packs may have a lack of a seal on the inner pouch.
- Class IITerminated2017-10-20The 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 d…
- Class IITerminated2016-11-03Terumo 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.
Related
- All facilities operated by Terumo BCT, INC.
- Terumo BCT, Inc.. (CO)
- Terumo BCT Vietnam Co., Ltd. (VN)
- TFB MANUFACTURING SRL (CR)
- Terumo BCT Europe N.V. (BE)
- TERUMO BCT, INC.- Littleton (CO)
- TERUMO BCT, LTD (GB)
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Terumo BCT STERILIZATION SERVICES, Inc. (FEI 3003094851) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3003094851-terumo-bct-sterilization-services-inc/
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