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  1. Recalls (Biologics)

2021 Biologics Recalls

Date Notification Brand Name Product Description Reason/Problem Company
August 18, 2021 Urgent Voluntary Recall: Level 1 Fast Flow Fluid Warming System, NORMOFLO Fluid Warmer and Level 1 Normothermic I.V. Fluid Administration Set

Level 1® Fluid Warmer
Model Numbers: H-1000, H-500

Level 1® Fluid Warming System
Model Numbers: H-1028, H-1200

NORMOFLO® Fluid Warmer
Model Number: H-1025

Level 1® Normothermic I.V. Fluid Administration Set
Model Numbers: D-100, D-300, D-50, D-60HL, D-70, DI-100, DI-300, DI-50, DI-60HL, DI-70

Smiths Medical ASD Inc., the manufacturer of record for Level 1® Fast Flow Fluid Warming System, NORMOFLO® Fluid Warmer and Level 1® Normothermic I.V. Fluid Administration Set, is voluntarily recalling certain models of these devices. Smiths Medical ASD Inc.
Minneapolis, MN
June 2, 2021 Urgent Voluntary Notification: FiberCel Fiber Viable Bone Matrix (“FiberCel”) - Lot Number: NMDS210011 Product Numbers- VBM9901, VBM9905, VBM9910 and Lot Number- NMDS210011 Aziyo Biologics, Inc., (“Aziyo”) is the manufacturer of record for FiberCel Fiber Viable Bone Matrix (“FiberCel”) and is voluntarily recalling one Lot of the FiberCel product out of an abundance of caution following a customer complaint that initially reported post-surgical infections for Tuberculosis. Aziyo Biologics, Inc.,
Richmond, CA
 
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