Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

475 results found for infusion pump Page 13 of 19
ICU
Class II Terminated
The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps a...
Reason: A possible interruption of therapy when an E321 error code occurs while using the infuser, which is caused by battery issues.
Z-2682-2017 July 19, 2017 Lake Forest, IL
ICU
Class II Terminated
The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps a...
Reason: A possible interruption of therapy when an E321 error code occurs while using the infuser, which is caused by battery issues.
Z-2676-2017 July 19, 2017 Lake Forest, IL
ICU
Class II Terminated
The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps a...
Reason: A possible interruption of therapy when an E321 error code occurs while using the infuser, which is caused by battery issues.
Z-2678-2017 July 19, 2017 Lake Forest, IL
ICU
Class II Terminated
The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps a...
Reason: A possible interruption of therapy when an E321 error code occurs while using the infuser, which is caused by battery issues.
Z-2677-2017 July 19, 2017 Lake Forest, IL
ICU
Class II Terminated
The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps a...
Reason: A possible interruption of therapy when an E321 error code occurs while using the infuser, which is caused by battery issues.
Z-2675-2017 July 19, 2017 Lake Forest, IL
ICU
Class II Terminated
The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps a...
Reason: A possible interruption of therapy when an E321 error code occurs while using the infuser, which is caused by battery issues.
Z-2680-2017 July 19, 2017 Lake Forest, IL
Medtronic Inc.
Class II Terminated
MiniMed 630G Insulin Infusion Pump, Catalog No. MMT-1715, MMT-1755.
Reason: Medtronic MiniMed is recalling the MiniMed 600 series insulin pump because it may become temporarily stuck, and the keypad becomes unresponsive.
Z-2603-2017 June 28, 2017 Northridge, CA
Medtronic Inc.
Class II Terminated
MiniMed 640G Insulin Infusion Pump, Catalog No. MMT-1511, MMT-1711, MMT-1512, MMT-1712, MMT-1551, MMT-1751, MMT-1552, MMT-1752.
Reason: Medtronic MiniMed is recalling the MiniMed 600 series insulin pump because it may become temporarily stuck, and the keypad becomes unresponsive.
Z-2604-2017 June 28, 2017 Northridge, CA
Medtronic Inc.
Class II Terminated
MiniMed 670G Insulin Infusion Pump, Catalog No. MMT-1580, MMT-1780, MMT-1782, MMT-1760.
Reason: Medtronic MiniMed is recalling the MiniMed 600 series insulin pump because it may become temporarily stuck, and the keypad becomes unresponsive.
Z-2605-2017 June 28, 2017 Northridge, CA
Medtronic Inc.
Class II Terminated
MiniMed 620G Insulin Infusion Pump, Catalog No. MMT-1510, MMT-1710, MMT-1550, MMT-1750.
Reason: Medtronic MiniMed is recalling the MiniMed 600 series insulin pump because it may become temporarily stuck, and the keypad becomes unresponsive.
Z-2602-2017 June 28, 2017 Northridge, CA
Cardiovascular Systems Inc
Class II Terminated
CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Number: 7-10014, Model Number: SIP-3000.
Reason: Cardiovascular Systems, Inc. (CSI). has initiated a recall to remove 1,396 7-10014 Saline Infusion Pumps (SIP) which were distributed by CSI between 07 April 2015 and 04 April 201...
Z-2122-2017 May 31, 2017 Saint Paul, MN
Baxter Healthcare Corporation
Class II Terminated
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library, Model #/Product Code 35700BAX2
Reason: SIGMA Spectrum Infusion Pumps with Master Drug Library, Software V8.00.02 contains an anomaly that may cause a Sharp Watchdog Timeout error message. Specifically, the software a...
Z-1693-2017 April 5, 2017 Medina, NY
Hospira Inc., A Pfizer Company
Class II Terminated
Plum 360 Infusion Pump, Software Version 15.02. The infusion pump is capable of delivering fluids for a variety of therapies such as parenteral, enteral, or epidural infusions
Reason: Depleted Battery alarm shows instead of Replace Battery. On battery power, ongoing therapy stops, alarms show and sound, pump shuts down after 3 minutes. On AC power, the pump reb...
Z-1682-2017 April 5, 2017 Lake Forest, IL
Medtronic Neuromodulation
Class II Terminated
SynchroMed II implantable drug infusion pump, Model 8637-40,
Reason: Medtronic received a complaint that there was an error code displayed on the programmer when the physician attempted to interrogate an implanted SynchroMed II pump. The error co...
Z-1694-2017 April 5, 2017 Minneapolis, MN
CareFusion 303, Inc.
Class II Terminated
Alaris System PC unit, model no. 8000 and 8015. The central programming, monitoring and power supply component for the Alaris infusion pump System.
Reason: Reports where the Low Battery alarm and/or the Very Low Battery alarm are not being triggered before the battery is discharged and all infusion channels are stopped.
Z-1520-2017 March 29, 2017 San Diego, CA
Smiths Medical ASD, Inc.
Class II Terminated
CADD Solis VIP Ambulatory Infusion Pump, Model 21-21210, Reorder 21-2120-0102-15,
Reason: 20 Pumps sold to the Finnish market contain a message in which one word in the message is mistranslated. When the user follows a specific set of key presses the pump will display t...
Z-1439-2017 March 22, 2017 Saint Paul, MN
Medtronic Neuromodulation
Class I Terminated
Medtronic SynchroMed II Implantable Drug Infusion System. This system includes: Model 8870 Software Application Card, Model 8840 N'Vision Clinician Programmer, and Model 8637 SynchroMed II Implanta...
Reason: Medtronic is following up to a May 2013 communication regarding the Priming Bolus function for the SynchroMed Infusion System. Medtronic is updating the Model 8870 software applic...
Z-0788-2017 March 8, 2017 Minneapolis, MN
CareFusion 303, Inc.
Class I Terminated
Alaris Pump Module, Model No. 8100 and AIL sensor kits, P/N 147083-102 and P/N 49000221. The Alaris Pump module is a large volume infusion pump offered under the Alaris System. The Alaris Pump modu...
Reason: During an infusion, a false Air-in-Line (AIL) alarm would cause the infusion to be interrupted.
Z-0950-2017 January 25, 2017 San Diego, CA
Baxter Healthcare Corp.
Class II Terminated
Baxter SIGMA Spectrum INFUSION PUMP with Master Drug Library, V8 Spectrum Infusion Pump, Product Code 35700BAX2, Unique Device Identifier GTIN 00085412091570, Rx ONLY -- Baxter Healthcare Corporatio...
Reason: A correction was issued for the SIGMA Spectrum Infusion Pump with Master Drug Library in order to replace speakers installed in pumps or included in spare part rear case assemblies...
Z-0671-2017 December 7, 2016 Deerfield, IL
Baxter Healthcare Corp.
Class II Terminated
sigma spectrum VOLUMETRIC INFUSION PUMP with Master Drug Library, V6 Spectrum Infusion Pump, Product Code 35700BAX and 35700BAXR, Unique Device Identifier GTIN 00085412091570, Rx ONLY -- Sigma, LLC Me...
Reason: A correction was issued for the SIGMA Spectrum Infusion Pump with Master Drug Library in order to replace speakers installed in pumps or included in spare part rear case assemblies...
Z-0670-2017 December 7, 2016 Deerfield, IL
Baxter Healthcare Corp.
Class II Terminated
V6 Rear Case Assembly, Product Code 35701, a replacement part for the SIGMA Spectrum Infusion Pump -- SIGMA LLC Medina, NY 14103 --- NOTE: The speakers are a part of the rear case assembly located in...
Reason: A correction was issued for the SIGMA Spectrum Infusion Pump with Master Drug Library and Rear Case Assembly in order to replace speakers installed in pumps or included in spare pa...
Z-0672-2017 December 7, 2016 Deerfield, IL
ICU Medical, Inc.
Class II Terminated
TRANSPAC¿ IV MONITORING KIT, NEONATAL, 24", WITH DISPOSABLE TRANSDUCER, 30 ML INTRAFLO¿ FLUSH (INFUSION PUMP), Item No. 42588-05 The Transpac Disposable Straight Pressure Transducer (DSPT) is an ex...
Reason: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
Z-0432-2017 November 23, 2016 San Clemente, CA
Bayer Healthcare
Class II Terminated
PET Infusion Pump
Reason: The Source Administration Sets (SAS) used with the Medrad Intego PET Infusion System do not meet pressure testing specifications in an occlusion situation when the product is more ...
Z-0400-2017 November 23, 2016 Indianola, PA
ICU Medical, Inc.
Class II Terminated
TRANSPAC¿ IV MONITORING KIT NEONATAL, 24", DISPOSABLE TRANSDUCER, 30 ML SQUEEZE FLUSH (INFUSION PUMP), Item No. 42586-05 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascul...
Reason: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
Z-0430-2017 November 23, 2016 San Clemente, CA
ICU Medical, Inc.
Class II Terminated
TRANSPAC¿ IV MONITORING KIT NEONATAL, 12", 3 STOPCOCKS, DISPOSABLE TRANSDUCER, 30 ML SQUEEZE FLUSH (FOR USE WITH INFUSION PUMP), Item No. 42634-05 The Transpac Disposable Straight Pressure Transduce...
Reason: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
Z-0444-2017 November 23, 2016 San Clemente, CA