BEUDAMED
    2 results · 12ms · Sources: EU EUDAMED, US FDA

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    All Outpatient and Coolspot single ceiling or single track Medical Examination Lights manufactured before August 2000. Products manufactured during or after August 2000 contain a redesigned pivot assembly and are not included in this recall. Affected products include: Model 100540 Fleximount SGL Ceiling, Serial No.''s less than SC995486 Model 100740 SGL Ceiling CS II, Serial No''s less than SCCS990745 Model 100580 SGL Trolley, Serial No.''s less than TRS962633 Model 100780 SGL Trolley OP II, Serial No.''s less than STOP97417 Model 102540 SGL Ceiling OP II, Serial No.''s less than SCOP003354.

    FDA Recall
    Terminated ·Burton Medical Products Corp·Product code KZF·February 19, 2004

    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