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Sources: EU EUDAMED, US FDA
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Fresenius Red Blood Cell Set, Catalog Number 9007601. The product is labeled in part: "RBC 9007601...STERILE...FRESENIUS KABI...Made in the Netherlands". Intended use: The Fresenius RBC red blood cell set (Art./Cat. No. 9007601) is used for depletion or exchange of red blood cells during therapeutic apheresis procedures on the Fresenius AS104 Blood Cell Separator Device. This set is used with a single stage separation chamber.
FDA Recall
Terminated
·Fresenius Kabi, LLC·Product code LKN·October 18, 2010
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012