Food, drugs, devices › Terumo BCT, Inc.
Device recall: HARVEST(R) TERUMOBCT, BMAC-30-07 Bone Marrow Procedure Pack, Private Practice / Clinical Use Only, REF 51416, Rx Only, S
Terumo BCT, Inc. (Lakewood, CO) initiated this device recall on 20 Oct 2017; FDA lists 2 product records under event 78307, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 93% of the 1,091 device enforcement events initiated in 2017 carry the same class.
Status: Terminated, terminated 21 Aug 2020. Initiation: voluntary: firm initiated. Terumo BCT, Inc. has 3 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Terumo BCT, Inc., Lakewood, CO.
Reason for recall
"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…"
Distribution
"CA, Co, MO, NY, PA, TX, VA, WI, Turkey, Austria, Spain"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0103-2018 | HARVEST(R) TERUMOBCT, BMAC-30-07 Bone Marrow Procedure Pack, Private Practice / Clinical Use Only, REF 51416, Rx Only, STERILE EO | 30 units | Class II | Terminated | 22 Nov 2017 |
| Z-0104-2018 | HARVEST(R) TERUMOBCT, BMAC2-120-01Bone Marrow Procedure Pack, REF 51423, Rx Only, STERILE EO | 281 units | Class II | Terminated | 22 Nov 2017 |
Context
Other enforcement events for Terumo BCT, Inc.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 20 Oct 2017 | HARVEST TERUMOBCT, GCP-10 Graft Delivery Pack, REF 51449, Rx Only, STERILE EO Harvest Graph Delivery System is a disposa | Device | Class II | 1 |
| 3 Nov 2016 | Adiprep Adipose Transfer System. Product Codes: 51431; 51432; 51433; 514001-347. | Device | Class II | 1 |
All 3 events for Terumo BCT, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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…"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "CA, Co, MO, NY, PA, TX, VA, WI, Turkey, Austria, Spain"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 21 Aug 2020. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.