Device product
HARVEST(R) TERUMOBCT, BMAC-30-07 Bone Marrow Procedure Pack, Private Practice / Clinical Use Only, REF 51416, Rx Only, STERILE EO
Z-0103-2018
Product summary
- Firm
- Terumo BCT, Inc.
- Event
- Event 78307
- Status
- Terminated
- Classification
- Class II
- Quantity
- 30 units
- Official record key
device-enforcement:Z-0103-2018
Official wording
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.
Code information: Lot 04A9938
Distribution pattern: CA, Co, MO, NY, PA, TX, VA, WI, Turkey, Austria, Spain
Derived failure modes
-
Unknown
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.