HARVEST(R) TERUMOBCT, BMAC-30-07 Bone Marrow Procedure Pack, Private Practice / Clinical Use Only, REF 51416, Rx Only, STERILE EO
Published November 22, 2017 · Recall initiated: October 20, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Terumo BCT, Inc.
- Distributor
- CA, Co, MO, NY, PA, TX, VA, WI, Turkey, Austria, Spain
- Lot
- Lot 04A9938
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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