Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 35700BAXRP Product Usage: The Baxter Sigma Spectrum Infusion Pump with master Drug Library is intended to be used for the c...
Reason: Service technician improperly documented final release testing on product, indicating that the full battery of release tests were performed when, in fact, several tests were omitte...
Z-1666-2018May 16, 2018Medina, NY
Smiths Medical ASD Inc.
Class IITerminated
Medfusion Syringe Pump 3500 Series The Medfusion¿ Syringe Infusion Pumps are indicated for the following uses: 1) Administration of fluids requiring precisely controlled infusion rates including b...
Reason: Certain Medfusion Syringe Pump Models, Series 3100, 3500, and 4000, may not recognize or may misidentify loaded medication syringes. The inability of a pump to recognize a syringe ...
Z-1135-2018March 28, 2018Minneapolis, MN
Smiths Medical ASD Inc.
Class IITerminated
Medfusion Syringe Pump 4000 Series The Medfusion¿ Syringe Infusion Pumps are indicated for the following uses: 1) Administration of fluids requiring precisely controlled infusion rates including b...
Reason: Certain Medfusion Syringe Pump Models, Series 3100, 3500, and 4000, may not recognize or may misidentify loaded medication syringes. The inability of a pump to recognize a syringe ...
Z-1134-2018March 28, 2018Minneapolis, MN
Smiths Medical ASD Inc.
Class IITerminated
Medfusion Syringe Pump 3010 Series The Medfusion¿ Syringe Infusion Pumps are indicated for the following uses: 1) Administration of fluids requiring precisely controlled infusion rates including b...
Reason: Certain Medfusion Syringe Pump Models, Series 3100, 3500, and 4000, may not recognize or may misidentify loaded medication syringes. The inability of a pump to recognize a syringe ...
Z-1136-2018March 28, 2018Minneapolis, MN
Baxter Healthcare Corporation
Class IITerminated
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) (GTIN 00085412091570); Model Numbers: 35700BAX and 35700ABB. Intended to be used for the controlled administration of fluids...
Reason: Certain infusion pumps may exhibit excessive wear of the pumping mechanism caused by a lack of lubrication, this could affect the occlusion of the tubing and result in over- or und...
Z-0971-2018March 21, 2018Medina, NY
Zevex Incorporated (dba Moog Medical Medical Devices Group)
Class IITerminated
MOOG Curlin Infusion Administration Set, Ref 340-4114, Non-DEHP Microbore Tubing with Non-Vented Bag Spike, packaged 20/box, for use with the MOOG Curlin Ambulatory Volumetric Infusion Pump, RX, Steri...
Reason: Particulate found on the Curlin spike.
Z-0697-2018March 7, 2018Salt Lake City, UT
Zevex Incorporated (dba Moog Medical Medical Devices Group)
Class IITerminated
MOOG Curlin Infusion Administration Set, Ref 340-4133, Non-DEHP Microbore Tubing with Non-Vented Bag Spike and Needleless Injection Port (Positive Pressure), packaged 20/box, for use with the Moog Cur...
Reason: Particulate found on the Curlin spike.
Z-0698-2018March 7, 2018Salt Lake City, UT
Zevex Incorporated (dba Moog Medical Medical Devices Group)
Class IITerminated
MOOG Curlin Infusion Administration Set, Ref 340-4169, Non-DEHP Microbore Tubing with Non-Vented Bag Spike and distal Ultrasite Needleless Injection Port (Positive Pressure), Anti-Siphon Valve include...
Reason: Particulate found on the Curlin spike.
Z-0702-2018March 7, 2018Salt Lake City, UT
Zevex Incorporated (dba Moog Medical Medical Devices Group)
Class IITerminated
MOOG Curlin Infusion Administration Set, Ref 340-4134, Non-DEHP Microbore Tubing with Non-Vented Bag Spike and Y-Site with Check Valve, packaged 20/box, for use with the Moog Curlin Ambulatory Volumet...
Reason: Particulate found on the Curlin spike.
Z-0699-2018March 7, 2018Salt Lake City, UT
Zevex Incorporated (dba Moog Medical Medical Devices Group)
Class IITerminated
MOOG Curlin Infusion Administration Set, Ref 340-4168, Non-DEHP Microbore Tubing with Non-Vented Bag Spike and distal Female Luer Y-Site with Check Valve, Anti-Siphon Valve included for Free Flow Prot...
Reason: Particulate found on the Curlin spike.
Z-0701-2018March 7, 2018Salt Lake City, UT
Zevex Incorporated (dba Moog Medical Medical Devices Group)
Class IITerminated
MOOG Curlin Infusion Administration Set, Ref 340-4166, Non-DEHP Microbore Tubing with Non-Vented Spike, Anti-Siphon Valve included for Free Flow Protection, packaged 20/box, for use with the Moog Curl...
Reason: Particulate found on the Curlin spike.
Z-0700-2018March 7, 2018Salt Lake City, UT
Smiths Medical ASD, Inc.
Class IITerminated
Custom Made Tracheostomy Device The CADD Administration Sets with Flow Stop are designed to be used with a variety of CADD ambulatory infusion pumps to allow fluid delivery from an IV bag.
Reason: Smiths Medical determined that a single custom Tracheostomy device had been shipped to the customer without required sterilization.
Reason: There is a possibility that specific lots of catheters that have recently been distributed may be at risk for an increased potential for kinking at the proximal end where the cathe...
Z-0537-2018February 14, 2018Minneapolis, MN
CareFusion 303, Inc.
Class IITerminated
Alaris Syringe Pump, Model 8110. The firm name on the label is CareFusion. The Alaris Syringe Pump module and Alaris PCA module are infusion pump modules for the Alaris System. The syringe pump an...
Reason: The syringe plunger grippers may fail to automatically close around the syringe plunger press when the gripper control knob has been closed.
Z-0322-2018January 17, 2018San Diego, CA
CareFusion 303, Inc.
Class IITerminated
Alaris PCA Pump, Model 8120. The firm name on the label is CareFusion. The Alaris Syringe Pump module and Alaris PCA module are infusion pump modules for the Alaris System. The syringe pump and PC...
Reason: The syringe plunger grippers may fail to automatically close around the syringe plunger press when the gripper control knob has been closed.
Z-0323-2018January 17, 2018San Diego, CA
Smiths Medical ASD Inc.
Class IITerminated
Medfusion, Syringe Infusion Pump, Software Version 6 (V6), Rx Only, Manufactured by Smiths Medical ASD, Inc., 1500 Eureka Park, Lower Pemberton, Ashford, Kent, TN25 4BF, UK. In the administration ...
Reason: Potential for the syringe barrel clamp mechanism to loosen, decreasing the pump's ability to accurately detect the diameter of the syringe barrel, resulting in the unit to initiate...
Z-0314-2018January 10, 2018Minneapolis, MN
Smiths Medical ASD Inc.
Class IITerminated
Medfusion, Syringe Infusion Pump, Software Version V1.1, Rx Only, Manufactured by Smiths Medical ASD, Inc., 1500 Eureka Park, Lower Pemberton, Ashford, Kent, TN25 4BF, UK. In the administration of...
Reason: Potential for the syringe barrel clamp mechanism to loosen, decreasing the pump's ability to accurately detect the diameter of the syringe barrel, resulting in the unit to initiate...
Z-0313-2018January 10, 2018Minneapolis, MN
Smiths Medical ASD Inc.
Class IITerminated
CADD-Legacy 1, Model 6400 Ambulatory Infusion Pump, REF 21-6400-51, PC 10008552-001, Smiths Medical ASD, Inc. Rx ONLY
Reason: Certain CADD Legacy 1, Ambulatory Infusion Pumps, may contain non-matching serial numbers. The label attached to the back of the pump may list a serial number that does not match t...
Z-0307-2018January 10, 2018Minneapolis, MN
ICU Medical Inc
Class IITerminated
ICU Mednet(TM) Medication Management Suite 6.1 and 6.21, Product Code/List Numbers: (a) 16037-64-01; MedNet 6.1 b) 16037-64-02; MedNet 6.1 c) 16037-64-03; MedNet 6.1 d) 16037-64-04; MedNet 6.21 ...
Reason: Issue 1: The MedNet Meds 6.1 and 6.21 programs, under certain conditions, can change the piggyback medication entry set settings for existing defined medication entries. This inclu...
Z-0195-2018December 13, 2017Lake Forest, IL
WalkMed, LLC
Class IITerminated
Reservoir Bag for WalkMed Infusion Pump Part Number 204820 Catalog Number IPR-86/10 65 mL and Reservoir Bag for WalkMed Infusion Pump Part Number 204821 Catalog Number IPR-150/10 150 mL The WalkMed R...
Reason: There have been reported incidents of fluid leaks at the luer connection. Leaks have been confirmed to originate from, or near, the reservoirs clearcolored female luer connecter.
Z-0090-2018November 22, 2017Englewood, CO
CareFusion 303, Inc.
Class IIOngoing
Alaris Pump Module model 8100 manufactured between November 2011 and March 2012; Alaris Pump Module serviced with LVP Mechanism Sub Assembly (P/N) 10942012 between November 2011 and March 2012; Al...
Reason: The recalling firm has received reports of increased or decreased flows that have occurred in certain pumps.
Z-0026-2018October 25, 2017San Diego, CA
Flowonix Medical, Inc.
Class IITerminated
PROMETRA II Programmable Infusion Pump, Implantable Infusion Pump, Catalog Number/REF 13827, Part Number PL-31790-02. Manufactured by: Flowonix Medical Inc., --- The correction involves the labeling...
Reason: Flowonix Medical received a report of a patient implanted with the Prometra II Programmable Pump who may have received a fatal drug overdose during an MRI procedure. The Prometra I...
Z-2740-2017July 26, 2017Mount Olive, NJ
ICU
Class IITerminated
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-2683-2017July 19, 2017Lake Forest, IL
ICU
Class IITerminated
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-2679-2017July 19, 2017Lake Forest, IL
ICU
Class IITerminated
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.