60 results
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11ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Version: 1.2.0 (1.2.0+85ela410) Caption Health, Caption AI, Ultrasound Imaging System Application Software (GMDN: 40873), UDI: (01)00860003586303(10)1.2.0)
FDA Recall
Terminated
·Caption Health·Product code QIH·May 19, 2021
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
AU/DxC AU Magnesium, Catalog/REF Number OSR6189, UDI 15099590010850
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code JGJ·December 8, 2021
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
Maquet Getinge BEQ-TOP 38300 ADULT CPS QID Material:701055862R01
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular, LLC·June 5, 2019
Maquet Getinge-BEQ-TOP 38300 ADULT CPS QID Material: 701055862
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular, LLC·June 5, 2019
Maquet Getinge-BEQ-TOP 38300 ADULT CPS QID Material: 701055862
FDA Recall
Terminated
·Maquet Cardiovascular, LLC·Product code DWF·April 18, 2019
Maquet Getinge BEQ-TOP 38300 ADULT CPS QID Material:701055862R01
FDA Recall
Terminated
·Maquet Cardiovascular, LLC·Product code DWF·April 18, 2019
Maquet Getinge-BEQ-TOP 25500 ECC 3/8 w/QiD Material: 701052461
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular, LLC·June 5, 2019
Maquet Getinge-BEQ-TOP 25500 ECC 3/8 w/QiD Material: 701052461
FDA Recall
Terminated
·Maquet Cardiovascular, LLC·Product code DWF·April 18, 2019
Maquet Getinge-BEQ-TOP 25503 TMC ¿ with BB & QiD Pedi Material:709000473
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular, LLC·June 5, 2019
Maquet Getinge-BEQ-TOP 25503 TMC with BB & QiD Pedi Material:709000473
FDA Recall
Terminated
·Maquet Cardiovascular, LLC·Product code DWF·April 18, 2019
BEQ-TOP 25500 ECC 3/8 w/QiD, Custom Tubing Kit, Catalog No. 701052461
FDA Enforcement
Class II
·Terminated·Datascope Corporation·May 16, 2018
BEQ-TOP 25500 ECC 3/8 w/QiD, Custom Tubing Kit, Catalog No. 701052461
FDA Recall
Terminated
·Datascope Corporation·Product code DTN·October 19, 2017
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