Terumo BCT, Inc.
Terumo BCT, Inc. appears in FDA public data with 4 recalls, 1 510(k) clearance, 12 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-0075-2018, Class II) was initiated on October 20, 2017. Its most recent 510(k) clearance was granted on September 11, 2015.
Summary
- Total Recalls
- 4
- 510(k) Clearances
- 1
- Inspections
- 12
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-0075-2018 | Class II | HARVEST TERUMOBCT, GCP-10 Graft Delivery Pack, REF 51449, Rx Only, STERILE EO Harvest Graph Deliver | October 20, 2017 |
| Z-0104-2018 | Class II | HARVEST(R) TERUMOBCT, BMAC2-120-01Bone Marrow Procedure Pack, REF 51423, Rx Only, STERILE EO | October 20, 2017 |
| Z-0103-2018 | Class II | HARVEST(R) TERUMOBCT, BMAC-30-07 Bone Marrow Procedure Pack, Private Practice / Clinical Use Only, R | October 20, 2017 |
| Z-0674-2017 | Class II | Adiprep Adipose Transfer System. Product Codes: 51431; 51432; 51433; 514001-347. | November 3, 2016 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K151368 | Spectra Optia Apheresis System, Spectra Optia Exchange Set (with AC Connection), Spectra Optia AC Co | September 11, 2015 |