233 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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Heparin I.V. Flush Syringe is available is pre-filled polypropylene syringes, 100 units/mL, 3 mL fill in a 12 mL syringe.
FDA Enforcement
Class III
·Terminated·Medefil Incorporated·March 12, 2014
Radial Artery Catheterization Kit; Product Codes: ASK-04020-AH, ASK-04020-MIHS, ASK-04120-HF1
FDA Enforcement
Class II
·Terminated·Arrow International Inc·June 6, 2018
Medefil Heparin I.V. Flush Syringe 10 units/mL; a polypropylene luer locking syringe containing Heparin Lock Flush Solution, USP, a sterile non-pyrogenic, isotonic injection; each mL in a Heparin I.V. Flush Syringe contains 10 units of heparin sodium derived from porcine intestinal mucosa and 9 mg of sodium chloride in water for injection; Medefil, Inc. Glendale Heights, IL 60139. The pre-filled syringes were packed as 60 syringes per dispenser box, 16 boxes per shipping carton in the following syringe configurations: a) NDC# 64253-222-21, catalog # MIH-2221: 1 mL fill in 6 mL syringe; b) NDC# 64253-222-23, catalog # MIH-2223: 3 mL fill in 6 mL syringe; c) NDC# 64253-222-35, catalog # MIH-2235: 5 mL fill in 12 mL syringe
FDA Recall
Terminated
·Medefil Incorporated·Product code NZW·November 1, 2010
Heparin I.V. Flush Syringe is available is pre-filled polypropylene syringes, 100 units/mL, 3 mL fill in a 12 mL syringe.
FDA Recall
Terminated
·Medefil Incorporated·Product code NZW·February 19, 2014
Medifil Heparin I.V. Flush Syringe 100 units/mL; a polypropylene luer locking syringe containing Heparin Lock Flush Solution, USP, a sterile non-pyrogenic, isotonic injection; each mL in a Heparin I.V. Flush Syringe contains 100 units of heparin sodium derived from porcine intestinal mucosa and 9 mg of sodium chloride in water for injection; Medefil, Inc., Glendale Heights, IL 60139 The pre-filled syringes were packed 60 syringes per dispenser box, 16 boxes per shipping carton in the following syringe configurations: a) NDC #64253-333-35, catalog #MIH-3335: 5 mL fill in 12 mL syringe b) NDC #64253-333-33, catalog #MIH-3333: 3 mL fill in 12 mL syringe c) NDC #64253-333-23, catalog #MIH-3323: 3 mL fill in 6 mL syringe
FDA Recall
Terminated
·Medefil Incorporated·Product code NZW·March 20, 2008
Radial Artery Catheterization Kit; Product Codes: ASK-04020-AH, ASK-04020-MIHS, ASK-04120-HF1
FDA Recall
Terminated
·Arrow International Inc·Product code DQX·April 11, 2018
Medefil Heparin I.V. Flush Syringe 100 units/mL; a polypropylene luer locking syringe containing Heparin Lock Flush Solution, USP, a sterile non-pyrogenic, isotonic injection; each mL in a Heparin I.V. Flush Syringe contains 100 units of heparin sodium derived from porcine intestinal mucosa and 9 mg of sodium chloride in water for injection; Medefil, Inc. Glendale Heights, IL 60139. The pre-filled syringes were packed as 60 syringes per dispenser box, 16 boxes per shipping carton in the following syringe configurations: a) NDC# 64253-333-33, catalog # MIH-3333: 3 mL fill in 12 mL syringe; b) NDC# 64253-333-35, catalog # MIH-3335: 5 mL fill in 12 mL syringe
FDA Recall
Terminated
·Medefil Incorporated·Product code NZW·November 1, 2010
Medefil Heparin I.V. Flush Syringe 1 units/mL; a polypropylene luer locking syringe containing Heparin Lock Flush Solution, USP, a sterile non-pyrogenic, isotonic injection; each mL in a Heparin I.V. Flush Syringe contains 1 units of heparin sodium derived from porcine intestinal mucosa and 9 mg of sodium chloride in water for injection; Medefil, Inc. Glendale Heights, IL 60139. The pre-filled syringes were packed as 60 syringes per dispenser box, 16 boxes per shipping carton in the following syringe configurations: a) NDC# 64253-444-22, catalog # MIH-4422: 2 mL fill in 6 mL syringe; b) NDC# 64253-444-25, catalog # MIH-4425: 5 mL fill in 6 mL syringe
FDA Recall
Terminated
·Medefil Incorporated·Product code NZW·November 1, 2010
Medefil Heparin I.V. Flush Syringe 10 units/mL; a polypropylene luer locking syringe containing Heparin Lock Flush Solution, USP, a sterile non-pyrogenic, isotonic injection; each mL in a Heparin I.V. Flush Syringe contains 10 units of heparin sodium derived from porcine intestinal mucosa and 9 mg of sodium chloride in water for injection; Medefil, Inc., Glendale Heights, IL 60139 The pre-filled syringes were packed 60 syringes per dispenser box, 16 boxes per shipping carton in the following syringe configurations: a) NDC #64253-222-35, catalog #MIH-2235: 5 mL fill in 12 mL syringe b) NDC #64253-222-33, catalog #MIH-2233: 3 mL fill in 12 mL syringe
FDA Recall
Terminated
·Medefil Incorporated·Product code NZW·March 20, 2008
Medefil Heparin I.V. Flush Syringe 1 unit/mL; a polypropylene luer locking syringe containing Heparin Lock Flush Solution, USP, a sterile non-pyrogenic, isotonic injection; each mL in a Heparin I.V. Flush Syringe contains 1 unit of heparin sodium derived from porcine intestinal mucosa and 9 mg of sodium chloride in water for injection; Medefil, Inc., Glendale Heights, IL 60139 The 5 mL fill in 6 mL syringes were packed 60 syringes per dispenser box, 16 boxes per shipping carton, NDC #64253-444-25, catalog #MIH-4425
FDA Recall
Terminated
·Medefil Incorporated·Product code NZW·March 20, 2008
Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( A= 26mm, B=112mm, C=82mm, D=12mm, E= 18.0f, F=.035'', G =40cm); Reorder number TFBB-26-82.
FDA Recall
Terminated
·Cook, Inc.·Product code MIH·December 20, 2004
Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( A= 30mm, B=141mm, C=111mm, D=12mm, E= 20.0f, F=.035'', G =40cm); Reorder number TFBB-30-111.
FDA Recall
Terminated
·Cook, Inc.·Product code MIH·December 20, 2004
Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( A= 30mm, B=112mm, C=82mm, D=12mm, E= 20.0f, F=.035'', G =40cm); Reorder number TFBB-30-82.
FDA Recall
Terminated
·Cook, Inc.·Product code MIH·December 20, 2004
Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-20-56-ZT, REF G48469, 16Fr ID/ 6.0 mm OD, Sterile.
FDA Recall
Terminated
·Cook, Inc.·Product code MIH·April 15, 2011
Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-10-71-ZT, REF G48444, 14 Fr ID/ 5.3 mm OD, Sterile.
FDA Recall
Terminated
·Cook, Inc.·Product code MIH·April 15, 2011
Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded iliac leg graft - distal cuff diameter 24 mm - usable length 54mm - delivery system 16 FR; Catalog no. TFLE-24-54.
FDA Recall
Terminated
·Cook, Inc.·Product code MIH·June 10, 2004
Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded iliac leg graft - distal cuff diameter 12 mm - usable length 88mm - delivery system 14 FR; Catalog no. TFLE-12-88.
FDA Recall
Terminated
·Cook, Inc.·Product code MIH·June 10, 2004
Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded iliac leg graft - distal cuff diameter 18 mm - usable length 37mm - delivery system 16 FR; Catalog no. TFLE-18-37.
FDA Recall
Terminated
·Cook, Inc.·Product code MIH·June 10, 2004
Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded iliac leg graft - distal cuff diameter 20 mm - usable length 54mm - delivery system 16 FR; Catalog no. TFLE-20-54.
FDA Recall
Terminated
·Cook, Inc.·Product code MIH·June 10, 2004
Cook brand Zenith AAA Bifurcated main body graft with the H&L-B One-Shot Introducer System, preloaded bifurcated main body graft - aortic graft diameter 26 mm - iliac leg diameters 11 mm - main body lengths contralateral limb 117mm ipsilateral limb 133 mm - delivery system 18 FR; Catalog no. TFB-26-117.
FDA Recall
Terminated
·Cook, Inc.·Product code MIH·June 10, 2004