2 results
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13ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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113" (287 cm) Appx 14.7 ml, 10 Drop Admin Set w/MicroClave" Clear, Remv 4-Way NanoClave" Stopcock, Remv 2-Gang 4-Way NanoClave" Stopcocks, Spin Luer w/ Filter Cap, 2 Ext.1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709120171(17)250201(30)50(10)4734446. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient's vascular system through the administration set's needle or catheter (which is inserted into a vein).
FDA Enforcement
Class II
·Terminated·ICU Medical, Inc.·October 28, 2020
113" (287 cm) Appx 14.7 ml, 10 Drop Admin Set w/MicroClave" Clear, Remv 4-Way NanoClave" Stopcock, Remv 2-Gang 4-Way NanoClave" Stopcocks, Spin Luer w/ Filter Cap, 2 Ext.1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709120171(17)250201(30)50(10)4734446. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient's vascular system through the administration set's needle or catheter (which is inserted into a vein).
FDA Recall
Terminated
·ICU Medical, Inc.·Product code FPA·July 6, 2020