4 results
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22ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Samco Bio-Tite Sterile Specimen Container, 120mL/53mm, Bio-Tite Blue Cap Catalog Number: 07 0006 The specimen containers are used for temporary collection, transfer, and/or storage of body fluids and solid specimen samples for the purpose of laboratory testing.
FDA Enforcement
Class II
·Terminated·Thermo Fisher Scientific (Monterrey)·June 3, 2020
Samco Bio-Tite Sterile Specimen Container, 120mL/53mm, Bio-Tite Blue Cap Catalog Number: 07 0006 The specimen containers are used for temporary collection, transfer, and/or storage of body fluids and solid specimen samples for the purpose of laboratory testing.
FDA Recall
Terminated
·Thermo Fisher Scientific (Monterrey) Blvd Apodaca 500 Apodaca Technology Park Apodaca Nuevo Leon 66600 Mexico·Product code FMH·April 29, 2020
Osteofil Allograft Paste (Bio) of varying sizes. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''.
FDA Recall
Terminated
·Regeneration Technologies, Inc.·Product code MQV·October 14, 2005
Reprocessed Pressure Tourniquet Cuff (PTC) Tourniquet cuffs are single- or dual-bladder inflatable cuffs connected to a tourniquet system via a hose assembly. When wrapped around a limb and inflated, tourniquet cuffs apply an adequate amount of pressure on the arterial blood flow in a limb to create a bloodless surgical field. Tourniquet cuffs are available in a variety of sizes to accommodate a wide range of limb circumferences.
FDA Enforcement
Class II
·Terminated·Stryker Sustainability Solutions·November 9, 2016