MedStream Programmable Infusion Pump, 20 mL, Product Code: 91-4200 The MedStream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal deli...
Reason: A small number of specific pumps may trigger a low battery alarm at the beginning of the implanted life.
Z-1571-2014May 21, 2014Raynham, MA
Codman & Shurtleff, Inc.
Class IITerminated
MedStream Programmable Infusion Pump, 40 mL, Product Code: 91-4201 The MedStream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal deli...
Reason: A small number of specific pumps may trigger a low battery alarm at the beginning of the implanted life.
Z-1572-2014May 21, 2014Raynham, MA
Medtronic Neuromodulation
Class IITerminated
Refill Kit 8551/856X (includes Models 8561, 8562 and 8564) for use with Medtronic Implantable Programmable Infusion Pumps. Product Usage: The Refill Kits are intended for use in refilling Medtroni...
Reason: Some refill kits in the affected lots may contain an extension tubing set that is occluded and healthcare professionals may be unable to aspirate or fill the SynchroMed pumps. The...
Z-1568-2014May 14, 2014Minneapolis, MN
Medtronic Neuromodulation
Class IITerminated
Medtronic SynchroMed¿ II Implantable Drug Infusion Pump, Model 8637-20, 8637-40. The implantable Medtronic SynchroMed II programmable pumps are part of an infusion system that stores and delivers ...
Reason: This recall provides important new information regarding overinfusion associated with the Medtronic SynchroMed II Implantable Pump. Overinfusion can result in a life-threatening ov...
Z-1570-2014May 14, 2014Minneapolis, MN
Hospira Inc.
Class ITerminated
GemStar Docking Station, used with GemStar infusion pump, in combination with other GemStar accessories such as the GemStar Lock Box and patient bolus cord. The docking station is also used for hosti...
Reason: There are two situations that may occur when using the GemStar Docking Station, List Number 13075-XX-XX, in conjunction with the GemStar infusion pump: 1) when the Docking Station ...
Z-1512-2014May 7, 2014Lake Forest, IL
Hospira Inc.
Class ITerminated
Hospira Acclaim Encore Infusion Pump Designed to deliver parenteral infusions including whole blood or red blood cell components and enteral fluids using a wide variety of standard administration ...
Reason: Broken door assemblies on the Hospira/Abbott Acclaim Encore infusion pumps. If the door assembly breaks, it may prevent the door from closing properly and unrestricted flow may oc...
Z-1483-2014May 7, 2014Lake Forest, IL
Hospira Inc.
Class ITerminated
Abbott Acclaim Infusion Pump Designed to deliver parenteral infusions including whole blood or red blood cell components and enteral fluids using a wide variety of standard administration sets and ...
Reason: Hospira has received customer reports of broken door assemblies on the Hospira/Abbott Acclaim Encore infusion pumps. If the door assembly breaks, it may prevent the door from closi...
Z-1482-2014May 7, 2014Lake Forest, IL
Baxter Healthcare Corp.
Class ITerminated
SIGMA SPECTRUM Volumetric Infusion Pump with Master Drug Library Product Usage: Sigma Spectrum Volumetric Infusion Pumps with Master Drug Library are intended to be used for the controlled adminis...
Reason: Baxter Healthcare Corporation has issued an Urgent Device Correction for the SIGMA SPECTRUM Volumetric Infusion Pump with Master Drug Library due to repeated System Error 322 occur...
Z-1484-2014April 30, 2014Deerfield, IL
WalkMed Infusion, LLC
Class IITerminated
Triton FP Infusion Pump, Part Number 400000, packaged in boxes. The Triton Volumetric Infusion Pump is indicated for delivering infusions of medications, as well as providing TPN (Total Parenteral ...
Reason: WalkMed Infusion is initiaing a recall on their Triton FP Infusion Pump, Part Number 400000 due to the label on the right side of the pump containing an incorrect instruction.
Z-1122-2014March 12, 2014Englewood, CO
Perrigo Diabetes Care
Class IITerminated
Orbit soft Infusion sets, 9 mm soft cannula, P10 (42") tubing; Single-Use Set Orbit Infusion Sets are sterile, non-pyrogenic, single-use devices intended to be used for subcutaneous delivery of medic...
Reason: Perrigo was notified by our supplier, Ypsomed AG, that they are recalling these batches due to being manufactured with a non-conforming female luer-lock connector. The luer-lock co...
Z-0990-2014February 26, 2014Alpharetta, GA
Tandem Diabetes Care Inc
Class ITerminated
T:slim Insulin Delivery System Insulin Infusion Pump
Reason: Specific lots of insulin cartridges that are used with the T:slim Insulin Pump may be at risk for leaking. A cartridge leak could result in the device delivering too much or too l...
Z-0827-2014February 19, 2014San Diego, CA
B. Braun Medical, Inc.
Class IITerminated
B. Braun AccuFlo Elastomeric Infusion Pump 200ML/H 100 ML Generally used for delivery of antibiotic and local anesthesia medications.
Reason: Internal testing of two lots of the AccuFlo CT-2000-100 Elastomeric Infusion Pump identified flow rates which are outside the specified infusion time and may result in overly rapid...
Z-0921-2014February 12, 2014Allentown, PA
Smiths Medical ASD, Inc.
Class IITerminated
Medfusion¿ 4000 Syringe Infusion Pumps Medfusion¿ 4000 Syringe Infusion Pumps are designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates. Th...
Reason: Smiths Medical is conducting a recall involving all Medfusion¿ 4000 Syringe Infusion Pumps. Smiths Medical has identified an issue with electrical shorting at the AC power recep...
Z-0540-2014December 25, 2013Saint Paul, MN
Hospira Inc.
Class IITerminated
Plum A+3 Infusion Pump System; List Number: 12348; Product Usage: The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across...
Reason: Hospira has received reports of distal pressure sensor calibration drift on Plum A+ Infusers. The following error codes may be displayed during setup or infusion signifying possibl...
Z-0206-2014November 20, 2013Lake Forest, IL
Hospira Inc.
Class IITerminated
Plum A+ Infusion Pump; List Number: 12391; Product Usage: The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the gen...
Reason: Hospira has received reports of distal pressure sensor calibration drift on Plum A+ Infusers. The following error codes may be displayed during setup or infusion signifying possibl...
Z-0207-2014November 20, 2013Lake Forest, IL
Baxter Healthcare Corp.
Class IITerminated
SIGMA SPECTRUM Infusion Pump with Master Drug Library. Intended to be used for the controlled administration of intravenous fluids.
Reason: Baxter Healthcare Corporation issued an Urgent Device Correction for the SIGMA SPECTRUM Infusion Pump with Master Drug Drug Library due to reports of upstream occlusion alarms and ...
Z-0197-2014November 20, 2013Deerfield, IL
Hospira Inc.
Class IITerminated
*** 1) Plum A+ Infusion Pump; List Number: 20678; Labeled in part: PLUM A+3; for use with Hospira MedNet; *** 2) Plum A+ Infusion Pump; List Number: 20679; Labeled in part: PLUM A+; ...
Reason: Hospira has received reports of distal pressure sensor calibration drift on Plum A+ Infusers. The following error codes may be displayed during setup or infusion signifying possibl...
Z-0209-2014November 20, 2013Lake Forest, IL
Hospira Inc.
Class IITerminated
Plum A+ Infusion Pump; List Number: 12618; Product Usage: The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the gen...
Reason: Hospira has received reports of distal pressure sensor calibration drift on Plum A+ Infusers. The following error codes may be displayed during setup or infusion signifying possibl...
Z-0208-2014November 20, 2013Lake Forest, IL
Hospira Inc.
Class IITerminated
Plum A+ Infusion Pump; List Number: 11973; Product Usage: The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the gen...
Reason: Hospira has received reports of distal pressure sensor calibration drift on Plum A+ Infusers. The following error codes may be displayed during setup or infusion signifying possibl...
Z-0205-2014November 20, 2013Lake Forest, IL
Hospira Inc.
Class IITerminated
Plum A+ Infusion Pump; List Number: 11971; Product Usage: The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the gen...
Reason: Hospira has received reports of distal pressure sensor calibration drift on Plum A+ Infusers. The following error codes may be displayed during setup or infusion signifying possibl...
Z-0204-2014November 20, 2013Lake Forest, IL
Baxter Healthcare Corp.
Class IITerminated
SIGMA SPECTRUM Infusion Pump with Master Drug Library component (SHARP LCD screen, 55074-2 revision B) Product Usage: Intended to be used as a visual aid during the controlled administration of in...
Reason: Baxter Healthcare Corporation is recalling the LCD display screen on the SIGMA SPECTRUM Infusion Pump with Master Drug Library for not meeting standards for withstanding an electro...
Z-0189-2014November 20, 2013Deerfield, IL
Hospira Inc.
Class IITerminated
Plum A+ Hyperbaric Infusion Pump; List Number 11005; Labeled in part: PLUM A+ HYPERBARIC; Product Usage: The Plum A+ Infusion Systems are a multipurpose family of devices that provides pr...
Reason: Hospira has received reports of distal pressure sensor calibration drift on Plum A+ Infusers. The following error codes may be displayed during setup or infusion signifying possibl...
Z-0203-2014November 20, 2013Lake Forest, IL
Medtronic MiniMed
Class IITerminated
Medtronic MiniMed Paradigm Reservoirs, Model No: MMT-326A (1.8mL) and MMT-332A (3.0mL) The model MMT-326A and MMT-332A are syringe type insulin reservoirs intended for use with Medtronic Paradigm s...
Reason: Medtronic is recalling certain lots of Medtronic MiniMed Paradigm Reservoirs MMT-326A (1.8mL) and MMT-332A (3.0mL) used with Medtronic Paradigm insulin pumps because they may have ...
Z-1986-2013August 28, 2013Northridge, CA
Iradimed Corporation
Class ITerminated
MRidium 1145 Dose Reduction System (DERS) drug library kit. (This is an option for the MRidium 3860+MR Infusion Pump System). The MRidium 3860+MRI Infusion pump are intended for general hospital o...
Reason: The Dose Error Reduction System (DERS) can indicate an incorrect recommended value for the rate via a specific key sequence during the initial infusion setup. This can result in a...
Z-1874-2013August 14, 2013Winter Park, FL
Codman & Shurtleff, Inc.
Class ITerminated
MedStream Programmable Infusion Pump- Implantable for the intrathecal delivery of Baclofen or Morphine Product Code:91-4200 (20ml pump) US 91-4200. Intended for the intrathecal delivery of Baclofe...
Reason: Miscalibrated Fill Level Sensor may affect dosing level