Recall Z-0104-2018— Terumo BCT, Inc.
Class II · Terminated
Class II FDA medical device recall by Terumo BCT, Inc., initiated 2017-10-20, terminated 2020-08-21. It names 3 FDA 510(k) clearances: K103340, K052925, K991430. Product: HARVEST(R) TERUMOBCT, BMAC2-120-01Bone Marrow Procedure Pack, REF 51423, Rx Only, STERILE EO. Reason: 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..
- Recalling firm
- Terumo BCT, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-10-20
- Terminated
- 2020-08-21
- Firm location
- Lakewood, CO, United States
510(k) clearances named in this recall
3 on FDA's record- K103340 — SMARTPREP2 BMAC SYSTEM, SMARTPREP PLATELET CONCENTRATION SYSTEM
- K052925 — SMARTPREP2 CENTRIFUGE SYSTEM
- K991430 — SMARTPREP CENTRIFUGE SYSTEM
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
HARVEST(R) TERUMOBCT, BMAC2-120-01Bone Marrow Procedure Pack, REF 51423, Rx Only, STERILE EO
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 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.