Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

475 results found for infusion pump Page 10 of 19
Flowonix Medical Inc
Class II Ongoing
Prometra II Programmable 20mL Pump. Catalog No. 93827 The device is an implantable infusion pump. GTIN-14 00810335020YYY (YYY= in-country language specific)
Reason: A pump alarm function anomaly in the pump firmware code may result in the pump not sending the expected error code notifications to the Programmer, or not emit an audible alarm ton...
Z-1125-2020 February 19, 2020 Mansfield, MA
Medtronic Inc.
Class I Ongoing
Medtronic MiniMed 640G Insulin Infusion Pump, Ref#s/Model(s) - MMT-1511, MMT-1711, MMT-1512, MMT-1712, MMT-1751, and MMT-1752 *Not for US Distribution
Reason: There have been reported incidents of a loose reservoir that can no longer be locked into the pump. The reservoir can become loose due to a broken or missing retainer ring that pre...
Z-0958-2020 February 19, 2020 Northridge, CA
Flowonix Medical Inc
Class II Ongoing
Prometra II 40mL Pump. Catalog No. 16827 The device is an implantable infusion pump. GTIN-14 00810335020242
Reason: A pump alarm function anomaly in the pump firmware code may result in the pump not sending the expected error code notifications to the Programmer, or not emit an audible alarm ton...
Z-1122-2020 February 19, 2020 Mansfield, MA
Flowonix Medical Inc
Class II Ongoing
Prometra Programmable 20mL Pump. Catalog No. 91827 The device is an implantable infusion pump. GTIN-14 00810335020XXX (XXX = in-country language specific)
Reason: A pump alarm function anomaly in the pump firmware code may result in the pump not sending the expected error code notifications to the Programmer, or not emit an audible alarm ton...
Z-1124-2020 February 19, 2020 Mansfield, MA
Flowonix Medical Inc
Class II Ongoing
Prometra II 20mL Pump. Catalog No. 13827 The device is an implantable infusion pump. GTIN-14 00810335020228
Reason: A pump alarm function anomaly in the pump firmware code may result in the pump not sending the expected error code notifications to the Programmer, or not emit an audible alarm ton...
Z-1121-2020 February 19, 2020 Mansfield, MA
Smiths Medical ASD Inc.
Class I Terminated
Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightweight and portable syringe infusion pump. The pump offers a variety of delivery modes programmable to meet specific patient ...
Reason: There is an anomaly in Medfusion 4000 Syringe Pump Firmware version 1.7.0 that could potentially result in loss of primary audible and visual battery alarm functionality, and inter...
Z-0610-2020 December 18, 2019 Minneapolis, MN
ICU Medical Inc
Class II Terminated
Plum 360 Infusion System With MedNet/ Smart Card Plug And Play Module, Model # 30010. Infusion pump.
Reason: A software malfunction of the infuser when used with a MedNet Custom Drug Library (CDL). When a new CDL is downloaded and installed on the infuser the infuser can become inoperabl...
Z-0171-2020 October 30, 2019 Lake Forest, IL
ICU Medical Inc
Class II Terminated
Infusion 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 pouch...
Reason: Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
Z-0129-2020 October 23, 2019 Lake Forest, IL
ICU Medical Inc
Class II Terminated
Infusion 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 ...
Reason: Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
Z-0130-2020 October 23, 2019 Lake Forest, IL
ICU Medical Inc
Class II Terminated
Infusion 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...
Reason: Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
Z-0139-2020 October 23, 2019 Lake Forest, IL
ICU Medical Inc
Class II Terminated
Infusion 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 pe...
Reason: Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
Z-0141-2020 October 23, 2019 Lake Forest, IL
ICU Medical Inc
Class II Terminated
Infusion 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 1...
Reason: Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
Z-0135-2020 October 23, 2019 Lake Forest, IL
ICU Medical Inc
Class II Terminated
Infusion 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 un...
Reason: Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
Z-0143-2020 October 23, 2019 Lake Forest, IL
ICU Medical Inc
Class II Terminated
Infusion 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, ...
Reason: Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
Z-0147-2020 October 23, 2019 Lake Forest, IL
ICU Medical Inc
Class II Terminated
Infusion 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 un...
Reason: Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
Z-0144-2020 October 23, 2019 Lake Forest, IL
ICU Medical Inc
Class II Terminated
Infusion 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 3...
Reason: Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
Z-0146-2020 October 23, 2019 Lake Forest, IL
ICU Medical Inc
Class II Terminated
Infusion 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...
Reason: Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
Z-0131-2020 October 23, 2019 Lake Forest, IL
ICU Medical Inc
Class II Terminated
Infusion 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,...
Reason: Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
Z-0137-2020 October 23, 2019 Lake Forest, IL
ICU Medical Inc
Class II Terminated
Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as High-Pressure Filter PRIMARY I.V. PLUMSET Convetible Pin, 104 Inch with Orange Polyethylene-...
Reason: Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
Z-0126-2020 October 23, 2019 Lake Forest, IL
ICU Medical Inc
Class II Terminated
Infusion 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 p...
Reason: Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
Z-0142-2020 October 23, 2019 Lake Forest, IL
ICU Medical Inc
Class II Terminated
Infusion 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 pe...
Reason: Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
Z-0140-2020 October 23, 2019 Lake Forest, IL
ICU Medical Inc
Class II Terminated
Infusion 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 Inc...
Reason: Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
Z-0133-2020 October 23, 2019 Lake Forest, IL
ICU Medical Inc
Class II Terminated
Infusion 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 Tu...
Reason: Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
Z-0127-2020 October 23, 2019 Lake Forest, IL
ICU Medical Inc
Class II Terminated
Infusion 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,...
Reason: Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
Z-0138-2020 October 23, 2019 Lake Forest, IL
ICU Medical Inc
Class II Terminated
Infusion 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 L...
Reason: Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
Z-0128-2020 October 23, 2019 Lake Forest, IL