Facility

TFB MANUFACTURING SRL

3 recall(s) on record — most severe on record: Class II.

Key facts

3recalls · worst Class II

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3020981987
Establishment type	Manufacture Medical Device for Another Party (Contract Manufacturer)
Location	Calle 58, Zona Franca La Lima La Lima, Guadalupe Cartago, CR 30106
Registration status	Active · expires 2026
Parent company	Terumo BCT, INC. (owner-operator 9002708)
Brand names	Spectra Optia Apheresis System; Spectra Optia BMP Set with Source Plasma Bag

Activity by year

Recalls (3)

Devices registered here (1)

Separator, Automated, Blood Cell, Diagnostic
Product code GKT (opens in a new tab) · Class II · Hematology · 21 CFR 864.9245

Recalls & enforcement

Class IITerminated2017-10-20
Certain lots of the Harvest Graft Delivery System GDP-10 Procedure Packs may have a lack of a seal on the inner pouch.
Class IITerminated2017-10-20
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 d…
Class IITerminated2016-11-03
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.

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. “TFB MANUFACTURING SRL (FEI 3020981987) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3020981987-tfb-manufacturing-srl/

Not open yet

Alerts for TFB MANUFACTURING SRL

Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.

Planned

Want a one-page facility brief?

A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.