3 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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Jessie Sterile Arm Suspension Kit, Product Code 711300, (previous product code 100401), Sample Kit S711300
FDA Recall
Terminated
·Aspen Surgical Products, Inc.·Product code CCX·July 23, 2021
Jessie Sterile Arm Suspension Kit, Product Code 711300, (previous product code 100401), Sample Kit S711300
FDA Enforcement
Class II
·Terminated·Aspen Surgical Products, Inc.·September 8, 2021
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