5 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Sierra Pre-Filled, Heparin Lock Flush Solution USP, 100 units/ml in 0.9% Sodium Chloride 120/Case, Catalog #1003-02, NDC #64054-1003-02, 5 mL Fill in a 12mL Syringe, For Single Use only, Sterile Solution Pathway, For IV Flush, Sierra Pre-Filled Inc., 455 W. Depot St. Angier, NC 27501
FDA Recall
Terminated
·AM2 PAT INC·Product code FOZ·December 11, 2007
rHead Recon Extended Stem Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
FDA Enforcement
Class II
·Terminated·Howmedica Osteonics Corp.·August 15, 2018
B. Braun, Heparin Lock Flush Solution USP, 100 units/ml, 120/Case, Ref #513612, NDC #64054-1003-02, 5 mL Fill in a 12mL Syringe, For Single Use only, Sterile Solution Pathway, For IV Flush, Distributed by B. Braun Medical, Inc., Bethlehem, PA 18018
FDA Recall
Terminated
·AM2 PAT INC·Product code FOZ·December 11, 2007
Alinity m System, Part No. 08N53-002
FDA Enforcement
Class II
·Terminated·Abbott Molecular, Inc.·January 12, 2022
CME America T-Syringe Pump - T34 - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical wound site).
FDA Enforcement
Class II
·Terminated·CME America, LLC·December 9, 2020