HARVEST(R) TERUMOBCT, BMAC2-120-01Bone Marrow Procedure Pack, REF 51423, Rx Only, STERILE EO
Check against the official notice below — it lists the full affected range.
Terumo BCT, Inc. is recalling HARVEST TERUMOBCT BMAC2-120-01 Bone Marrow Procedure Packs with catalog numbers 51416 and 51423 because the patient labels included in these packs contain incorrect lot numbers, catalog numbers, and expiry dates. The correct lot number appears on the box label itself. A total of 281 units have been distributed across California, Colorado, Missouri, New York, Pennsylvania, Texas, Virginia, Wisconsin, Turkey, Austria, and Spain. The affected lot is 04A9939.
The FDA notes that because the product is marketed as sterile, further investigation is needed to determine whether the product was cleared with a sterility claim and to fully assess the safety risk. The recall record does not specify a remedy or corrective action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. Distribution: CA, Co, MO, NY, PA, TX, VA, WI, Turkey, Austria, Spain Quantity: 281 units Lot/code info: UDI Case: 35020583514233, 51423 Each: 05020583514232, Lot 04A9939
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.