Harvest(r) Terumobct recall: Sterility Concern
HARVEST(R) TERUMOBCT, BMAC2-120-01Bone Marrow Procedure Pack, REF 51423, Rx Only, STERILE EO
Why was Harvest(r) Terumobct recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI Case: 35020583514233, 51423 Each: 05020583514232, Lot 04A9939
- Product
- HARVEST(R) TERUMOBCT, BMAC2-120-01Bone Marrow Procedure Pack, REF 51423, Rx Only, STERILE EO
- Recalling firm
- Terumo BCT, Inc.
- Quantity
- 281 units
- Distribution
- CA, Co, MO, NY, PA, TX, VA, WI, Turkey, Austria, Spain
- Recall date
- November 22, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)