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U.S. Department of Health and Human Services

Medical Device Recalls
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Assure COVID-19 IgG/IgM Rapid Test Device that include: 1) Pouch Label - FaStep Rapid Diagnostic T... 2 04/16/2021 AZURE BIOTECH INC
BK Medical ApS Ultrasound System Scanner bk2300 - Model #: bk3500 with software releases 1.2.0, 1.2... 2 08/03/2016 B-K Medical A/S
ALLERGAN UNIVERSAL FILL KIT, REF No. 7M2804. for tissue expander inflation. 2 11/03/2023 B. Braun Medical, Inc.
BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: PowerGlide Midline Ca... 2 03/13/2015 Bard Access Systems
Catalog # BEK3411, Ecomomy Jamshidi Bone Marrow Biopsy Tray, 11 G X 4"Biopsy/Aspiration needle, ster... 2 10/19/2021 Bard Peripheral Vascular Inc
HALO Ultra Ablation Catheter: Rx only; for use only with the Halo Flex Energy generator and accesso... 2 07/06/2011 Barrx Medical, Inc.
Energy FX: a) original Aluminum (100-3A) b) sleek (adult and kid & pet) (100-3B) 2 11/08/2019 Basic Reset Inc.
1) The HomeChoice automated peritoneal dialysis system. Dataplate located on the device is labeled ... 2 08/22/2016 Baxter Healthcare Corp.
The HomeChoice Pro APD System is a peritoneal dialysis system. The HomeChoice Pro Automated Perso... 2 03/18/2015 Baxter Healthcare Corp.
NaviCare Nurse Call System provides a comprehensive communication and information system that pla... 2 05/13/2022 Baxter Healthcare Corporation

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