The Plum A+ Infusion System is designed to meet the fluid delivery requirements of today's evolving healthcare environments. It is a cassette based multi-function infusion system. The Plum A+ allows t...
Reason: One lot of alarm assemblies used in Plum A+ and Plum A+3 infusion pumps may fail to sound at all volume levels.
Z-1075-2015March 4, 2015Lake Forest, IL
Hospira Inc.
Class ITerminated
The Plum A+ Infusion System is designed to meet the fluid delivery requirements of today's evolving healthcare environments. It is a cassette based multi-function infusion system. The Plum A+ allows t...
Reason: One lot of alarm assemblies used in Plum A+ and Plum A+3 infusion pumps may fail to sound at all volume levels.
Z-1071-2015March 4, 2015Lake Forest, IL
Hospira Inc.
Class ITerminated
The Plum A+ Infusion System is designed to meet the fluid delivery requirements of today's evolving healthcare environments. It is a cassette based multi-function infusion system. The Plum A+ allows t...
Reason: One lot of alarm assemblies used in Plum A+ and Plum A+3 infusion pumps may fail to sound at all volume levels.
Z-1073-2015March 4, 2015Lake Forest, IL
Hospira Inc.
Class ITerminated
The Plum A+ Infusion System is designed to meet the fluid delivery requirements of today's evolving healthcare environments. It is a cassette based multi-function infusion system. The Plum A+ allows t...
Reason: One lot of alarm assemblies used in Plum A+ and Plum A+3 infusion pumps may fail to sound at all volume levels.
Reason: CME America is recalling the BodyGuard and BodyGuard 323 Infusion pumps due to the potential for an over delivery.
Z-1126-2015February 25, 2015Golden, CO
Animas Corporation
Class IITerminated
Animas Vibe Insulin Infusion Pump. This product is indicated for continuous subcutaneous infusion of insulin for the treatment of diabetes and has a continuous glucose monitoring feature.
Reason: Calibration factors in the pump overwritten during a programming step. The force sensor could send a lower signal value to the pump processor, with loss of prime warnings, occlusio...
Z-1034-2015February 11, 2015West Chester, PA
CareFusion 303, Inc.
Class IITerminated
SmartSite Low Sorbing Infusion Set, Model No. 10015862 The SmartSite Infusion Sets are used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein...
Reason: CareFusion is recalling the SmartSite Low Sorbing Infusion set due to disconnection and leakage issues.
Reason: Tubing may detach at the connect/disconnect location on the MiniMed Silhouette and MiniMed Sure-T infusion sets. Detachment causes interrupted insulin delivery and the pump will no...
Z-0524-2015December 17, 2014Northridge, CA
Hospira Inc.
Class IITerminated
GemStar infusion pump, list numbers 13086 and 13087, GemStar infusion pump (pain management) list number 13088. Product Usage The pump is suitable for intravenous, arterial, subcutaneous, short-t...
Reason: Some patients are obtaining access to the dosage reset codes required to change the settings on GemStar infusion pumps and are subsequently changing the infusion rate set by their ...
Z-0422-2015December 3, 2014Lake Forest, IL
Hospira Inc.
Class IITerminated
GemStar infusion pump, list numbers 13000 and 13100, GemStar Infusion Pump (pain management) list number 13150. Product Usage The pump is suitable for intravenous, arterial, subcutaneous, short-t...
Reason: Some patients are obtaining access to the dosage reset codes required to change the settings on GemStar infusion pumps and are subsequently changing the infusion rate set by their ...
Z-0421-2015December 3, 2014Lake Forest, IL
Smiths Medical ASD, Inc.
Class IITerminated
CADD-Solis Medication Safety Software, Administrator CD, Version 3.1, REF 21-2194-0301-01. Product Usage: The CADD-Solis Medication Safety Software- Administrator allows use of a computer to crea...
Reason: Smiths Medical has identified an issue with a single batch (Lot Number 2752712) of CADD"-Solis Medication Safety Software Administrator 3.1 CDs. CADD"-Solis Medicat...
Z-0166-2015November 12, 2014Saint Paul, MN
Hospira Inc.
Class ITerminated
The GemStar Power Supply is an accessory for the GemStar Infusion Pump. It is a two piece assembled switching power supply. The Power Supply converts alternating current (AC) line input voltage of 120...
Reason: The GemStar Infusion pump may not receive direct current (DC) power from the power supply. In one instance, smoke was observed and the GemStar pump was operating on battery power w...
Z-0095-2015November 5, 2014Lake Forest, IL
Animas Corporation
Class IITerminated
Animas Vibe Insulin Infusion Pump and System. These products are indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes.
Reason: Animas determined that keypad wear over time was contributing to an increased complaint rate associated with damaged keypads on the Vibe Insulin Infusion Pump and System. Animas ha...
Z-0137-2015November 5, 2014West Chester, PA
Hospira Inc.
Class ITerminated
The GemStar Power Supply is an accessory for the GemStar Infusion Pump. It is a two piece assembled switching power supply. The Power Supply converts alternating current (AC) line input voltage of 120...
Reason: The GemStar Infusion pump may not receive direct current (DC) power from the power supply. In one instance, smoke was observed and the GemStar pump was operating on battery power w...
Z-0096-2015November 5, 2014Lake Forest, IL
Roche Diagnostics Operations, Inc.
Class IITerminated
ACCU-CHEK Spirit Combo insulin infusion pump sold as part of Accu-Chek Combo System Product Usage: The ACCU-CHEK Combo System is meant only for single-patient use; the device may not be used for s...
Reason: The insulin pump may lose time and date settings during a power interruption (such as a battery change) due to a faulty capacitor. If the capacitor fails, the time and date will re...
Z-0146-2015November 5, 2014Indianapolis, IN
Animas Corporation
Class IITerminated
Animas Vibe Insulin Infusion Pump. This product is indicated for continuous subcutaneous infusion of insulin for the treatment of diabetes and has a continuous glucose monitoring feature.
Reason: Animas determined that the Hebrew language translation in the Vibe Insulin Infusion Pump was incorrect and could lead to potential patient confusion. In addition, one line of Hebre...
Z-0136-2015November 5, 2014West Chester, PA
Baxter Healthcare Corp.
Class IITerminated
SPECTRUM Pump, Model No. 35700BAX. Intended to be used for the controlled administration of intravenous fluids.
Reason: One Service Technician may not have correctly serviced specific Sigma Spectrum Infusion Pumps according to established procedures during the time period of 5/5/2014 through 6/3/201...
Reason: Medtronic is recalling the Medtronic MiniMed Paradigm Insulin Infusion Pumps because they have received reports that users have accidentally programmed the pump to deliver the maxi...
Z-2544-2014September 3, 2014Northridge, CA
Medtronic Neuromodulation
Class IITerminated
Medtronic Ascenda Intrathecal Catheter models 8780 and 8781, and Ascenda Intrathecal Catheter Pump Segment Revision Kit, model 8784. The Ascenda Intrathecal Catheter is part of an infusion system...
Reason: Medtronic is removing specific lots of the Ascenda Intrathecal Catheters and Revision Kits, which are used with the implantable SynchroMed drug infusion pump. This recall is being...
Z-2172-2014August 20, 2014Minneapolis, MN
Hospira Inc.
Class IITerminated
GemStar infusion pump, List numbers 13000 and 13100, GemStar Infusion Pump (pain management) List number 13150. Used for intravenous, arterial, subcutaneous, short-term epidural infusion and ...
Reason: The connection between the beeper subassembly and the pump may fail. The GemStar infusion pump will identify this failure during the "self-test" while powering up which will result...
Z-2031-2014July 16, 2014Lake Forest, IL
Hospira Inc.
Class IITerminated
The Hospira MedNet Medication Management Suite (MMS). Product Usage: The Hospira MedNet Medication Management Suite (MMS) is intended to facilitate networked communication between MMS compatible c...
Reason: Hospira MedNet 5.5, 5.8.1, and 5.8.2 contains software defect where the dosing units of "nanog/kg/min" and "milliUnits/min" are not sent to a Plum A+ device (Version 13.40, 13.41, ...
Z-2027-2014July 16, 2014Lake Forest, IL
Hospira Inc.
Class IITerminated
LifeCare 5000 Pump (Plum 1.6) infusion pump, indicated for volumetric infusion of critical drugs and fluids by intravenous (I.V.) administration.
Reason: There is the potential for the door roller assembly on the Plum LifeCare 5000 Series and Plum XL families of infusers to break. In the event of a broken door roller pin, the door c...
Z-1702-2014June 11, 2014Lake Forest, IL
Hospira Inc.
Class IITerminated
Plum XL, Micro Macro Plum XL3 with data port, and Micro Macro Plum XL with data port infusion pumps, indicated for intravenous, arterial, short-term epidural, and parenteral administration of general...
Reason: There is the potential for the door roller assembly on the Plum LifeCare 5000 Series and Plum XL families of infusers to break. In the event of a broken door roller pin, the door c...
Z-1703-2014June 11, 2014Lake Forest, IL
Hospira Inc.
Class IITerminated
Plum XL3 Multi line Infusion System, Micro Macro Plum XL3 Multi line Infusion System, and Micro Macro Plum XL Infusion System. Infusion pumps for intravenous. arterial, short-term epidural, and paren...
Reason: There is the potential for the door roller assembly on the Plum LifeCare 5000 Series and Plum XL families of infusers to break. In the event of a broken door roller pin, the door c...
Z-1704-2014June 11, 2014Lake Forest, IL
CareFusion 303, Inc.
Class ITerminated
Alaris Pump model 8100 with software version 9.1.18 and software upgrade kits with "Delay Until" Option and "Multidose" Feature The Alaris Pump module is a large volume infusion pump offered under ...
Reason: CareFusion is recalling the Alaris Pump model 8100 version 9.1.18 because it may have a software issue that results in situation where the pump module will not properly delay an in...