Medical device recalls
39180 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2019-10-23FDA-DeviceVital Scientific N.V.Class IIV-Twin, Catalog # 6002-800, UDI # 03661540600180 Product Usage: automated chemistry analyzer intended for clinical use
The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced.
- 2019-10-23FDA-DeviceVital Scientific N.V.Class IIViva-E, Catalog # 6002-380, UDI # 03661540600050 Product Usage: automated chemistry analyzer intended for clinical use
The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced.
- 2019-10-23FDA-DeviceVital Scientific N.V.Class IIViva - JR, catalog # 6002-940, UDI # 03661540600210 Product Usage: automated chemistry analyzer intended for clinical use
The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced.
- 2019-10-23FDA-DeviceRoche Diagnostics Operations, Inc.Class IIICobas c Bilirubin Total Gen.3 Catalog Number: 05795419190 - Product Usage: In vitro test for the quantitative determination of the total bilirubin in serum and plasma of adults and neonates on Roche/Hitachi cobas c systems.
Due to low Quality Control recovery and invalid Calibration.
- 2019-10-23FDA-DeviceRoche Diagnostics Operations, Inc.Class IIIRoche Diagnostics cobas Integra Albumin Gen.2 Catalog Number: 05166861190 - Product Usage: In vitro test for the quantitative determination of the albumin in human serum and plasma on Roche/Hitachi cobas c systems.
Due to low Quality Control recovery and invalid Calibration.
- 2019-10-23FDA-DeviceXodus Medical IncClass IICautery Tip Cleaner REF: 30500 Product Usage: electrosurgical accessory
The sterile barrier of some devices may have been affected
- 2019-10-23FDA-DeviceXodus Medical IncClass IIElectrosurgical Tip Cleaner REF: 62-8499-001 Product Usage: electrosurgical accessory
The sterile barrier of some devices may have been affected
- 2019-10-23FDA-DeviceXodus Medical IncClass IIElectrosurgical Tip Cleaner REF: 138029 Product Usage: electrosurgical accessory
The sterile barrier of some devices may have been affected
- 2019-10-23FDA-DeviceSiemens Healthcare Diagnostics, Inc.Class IISiemens Atellica CH 930 Analyzer. Siemens Material Number (SMN): 11067000 Product Usage: automated, clinical chemistry analyzer to perform in vitro diagnostic tests on clinical specimens
Atellica CH 930 Analyzer - Erroneous Indices for Hemolysis and Lipemia in Software versions 1.19.2 and below
- 2019-10-23FDA-DeviceICU Medical IncClass IIInfusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set with NRFit Connector Yellow-Striped Microbore, 0.2 Micron Filter, PAV, 123 Inch. 1 unit per pouch; 50 pouches per case
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
- 2019-10-23FDA-DeviceICU Medical IncClass IIInfusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set with NRFit Connector Yellow-Striped Microbore, 0.2 Micron Filter 301 cm / 8.3 mL. 1 unit per blister; 40 blisters per case. Not distributed in the U.S.
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
- 2019-10-23FDA-DeviceICU Medical IncClass IIInfusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as PLUM Epidural Set with NRFit Connector Yellow-Striped Tubing, Distal Microbore Tubing, 0.2 Micron Filter, 107 Inch. 1 unit per pouch; 48 pouches per case
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
- 2019-10-23FDA-DeviceICU Medical IncClass IIInfusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter 301 cm / 8.3 mL. 1 unit per blister; 40 blisters per case . Not distributed in the U.S.
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
- 2019-10-23FDA-DeviceICU Medical IncClass IIInfusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter 301 cm / 8.3 mL. 1 unit per blister; 40 blisters per case . Not distributed in the U.S.
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
- 2019-10-23FDA-DeviceICU Medical IncClass IIInfusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 0.2 Micron Filter Set Non-Vented, Microbore, 293 cm / 8.1 mL. 1 unit per pouch; 1 unit per blister; 40 blisters per case. Not distributed in the U.S.
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
- 2019-10-23FDA-DeviceICU Medical IncClass IIInfusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 1.2 Micron Filter Set Non-Vented, Microbore 311 cm / 8.4 mL. 1 unit per pouch; 1 unit per blister; 40 blisters per case . Not distributed in the U.S.
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
- 2019-10-23FDA-DeviceICU Medical IncClass IIInfusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 1.2 Micron Filter Set Non-Vented, Microbore 311 cm / 8.4 mL. 1 unit per pouch; 1 unit per blister; 40 blisters per case . Not distributed in the U.S.
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
- 2019-10-23FDA-DeviceICU Medical IncClass IIInfusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as Primary PLUM Set, 15 Micron Filter in Sight Chamber, CLAVE Secondary Port, 0.2 Micron Filter, Polyethylene Lined Light Resistant Tubing, Distal Microbore Tubing, Secure Lock 269 cm / 14 mL. 1 unit per pouch; 50 pouches per case. Not distributed in the U.S.
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
- 2019-10-23FDA-DeviceICU Medical IncClass IIInfusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as Primary PLUM Set 15 Micron Filter in Sight Chamber, CLAVE Secondary Port, 0.2 Micron Filter, CLAVE Y-Site, Polyethylene Lined Light Resistant Tubing, Distal Microbore Tubing, Secure Lock 272 cm / 15 mL. 1 unit per pouch; 50 pouches per case. Not distributed in the U.S.
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
- 2019-10-23FDA-DeviceICU Medical IncClass IIInfusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as Primary PLUM Set 15 Micron Filter in Sight Chamber, CLAVE Secondary Port, 0.2 Micron Filter, CLAVE Y-Site, Polyethylene Lined Light Resistant Tubing, Distal Microbore Tubing, Secure Lock 272 cm / 15 mL. 1 unit per pouch; 50 pouches per case. Not distributed in the U.S.
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
- 2019-10-23FDA-DeviceICU Medical IncClass IIInfusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as PRIMARY PLUMSET 15 Micron Filter in Sight Chamber, CLAVE Port, 0.2 Micron Filter, CLAVE Y-Site, PE Lined Light Resistant Tubing, Distal Microbore Tubing 272 cm / 15 mL. 1 unit per pouch; 50 pouches per case. Not distributed in the U.S.
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
- 2019-10-23FDA-DeviceICU Medical IncClass IIInfusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set with NRFit Connector Yellow-Striped Microbore, 0.2 Micron Filter 119 Inch. 1 unit per pouch; 50 pouches per case
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
- 2019-10-23FDA-DeviceICU Medical IncClass IIInfusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 1.2 Micron Filter Set Non-Vented, Microbore, PAV, 123 Inch. 1 unit per pouch; 50 pouches per case
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
- 2019-10-23FDA-DeviceICU Medical IncClass IIInfusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 0.2 Micron Filter Set Non-Vented, Microbore, PAV, CLAVE Y-Site, 122 Inch. 1 unit per pouch; 50 pouches per case
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
- 2019-10-23FDA-DeviceICU Medical IncClass IIInfusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter, PAV 123 inch. 1 unit per pouch; 50 pouches per case
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
- 2019-10-23FDA-DeviceICU Medical IncClass IIInfusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter 119 Inch. 1 unit per pouch; 50 pouches per case
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
- 2019-10-23FDA-DeviceICU Medical IncClass IIInfusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 0.2 Micron Filter Set, Microbore, CLAVE Y-Site, 118 Inch. 1 unit per pouch; 50 pouches per case
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
- 2019-10-23FDA-DeviceICU Medical IncClass IIInfusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 1.2 Micron Filter Set Microbore, 122 Inch. 1 unit per pouch; 50 pouches per case
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
- 2019-10-23FDA-DeviceICU Medical IncClass IIInfusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as Primary PLUM Set Yellow Striped Tubing, Distal Microbore Tubing, 0.2 Micron Filter, Secure Lock, 107 Inch. 1 unit per pouch; 48 pouches per case
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
- 2019-10-23FDA-DeviceICU Medical IncClass IIInfusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as Primary PLUM Set 0.2 Micron Filter, Prepierced Y-Site, Polyethylene Lined Light Resistant Tubing, Distal Microbore Tubing, Secure Lock, 104 Inch. 1 unit per pouch; 50 pouches per case
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
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