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, PAV 123 inch. 1 uni...
Reason: Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
Z-0132-2020October 23, 2019Lake Forest, IL
ICU Medical Inc
Class IITerminated
Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as PLUM Epidural Set with NRFit Connector Yellow-Striped Tubing, Distal Microbore Tubing, 0.2 M...
Reason: Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
Z-0145-2020October 23, 2019Lake Forest, IL
ICU Medical Inc
Class IITerminated
Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as PRIMARY PLUMSET 15 Micron Filter in Sight Chamber, CLAVE Port, 0.2 Micron Filter, CLAVE Y-Si...
Reason: Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
Z-0136-2020October 23, 2019Lake Forest, IL
ICU Medical Inc
Class IITerminated
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, PAV, 123 Inch. 1 unit pe...
Reason: Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
Z-0134-2020October 23, 2019Lake Forest, IL
B. Braun Medical, Inc.
Class ITerminated
B.Braun Infusomat Space Volumetric Infusion Pump Administration Set, Catalog Number 363032
Reason: Potential for the Infusion Pump Administration Set to leak and/or disconnect at the bonded joint between the tubing and Injection Site (Y-Site).
Z-2489-2019October 2, 2019Allentown, PA
Smiths Medical ASD Inc.
Class IITerminated
Medfusion¿ Model 4000 Syringe Infusion Pump, with PharmGuard¿ Server Software (PGS). Sold under the following names: MEDFUSION¿ 4000 Pump V1.0; MEDFUSION¿ 4000 Pump V1.1, v1.1.1, v1.1.2; ME...
Reason: Customers who utilize PharmGuard¿ Server Software (PGS) with Medfusion¿ 4000 pumps manufactured prior to November 10, 2017, may experience wireless network connectivity issues on...
Z-2554-2019October 2, 2019Minneapolis, MN
Fenwal Inc
Class ITerminated
VOLUMAT MC AGILIA US, Infusion Pump, REF Z021135, software versions 1.7 and 1.9a Product Usage: The Volumat MC Agilia is a piece of transportable medical equipment intended to be used in healthcar...
Reason: The firm is correcting four software anomalies and KVO (keep vein open) end of infusion alarm priority in Software versions 1.7 and 1.9a of Volumat MC Agilia Software and versions ...
Z-2064-2019August 21, 2019Lake Zurich, IL
Fenwal Inc
Class ITerminated
Vigilant Agilia, Vigilant Drug'Lib, REF Z073476, versions 1.0 and 1.1 Product Usage: Vigilant Drug Lib is Dose Error Reduction Software that, when used in combination with Volumat MC Agilia infus...
Reason: The firm is correcting four software anomalies and KVO (keep vein open) end of infusion alarm priority in Software versions 1.7 and 1.9a of Volumat MC Agilia Software and versions ...
Z-2065-2019August 21, 2019Lake Zurich, IL
Zyno Medical LLC
Class IITerminated
Zyno Medical Administration Set -105"ADMIN SET 20DP, W/2 Y SITE, CVCLMPS- For Use with Zyno Medical Infusion pumps or Gravity Feed Product Code:B2-70072
Reason: Administration sets assembled with inverted pinch clamp cause the fluid from the distal end of the administration set to be pumped to the proximal end of the tubing when secondary ...
Z-2058-2019July 31, 2019Natick, MA
Zevex Incorporated (dba MOOG Medical Devices Group)
Class IITerminated
MOOG Curlin Infusion Administration Set, REF 340-4130, Non-DEHP Tubing with Non-Vented Bag Spike and Vented 0.2 Micron Filter, packaged 20 sets/carton, sterile. Product Usage: Administration set t...
Reason: Administration sets leaked at the filter.
Z-2053-2019July 31, 2019Salt Lake City, UT
Zyno Medical LLC
Class IITerminated
Zyno Medical Administration Set -105"ADMIN SET 20DP W/FILTER 2YSITES CLMP- For Use with Zyno Medical Infusion pumps or Gravity Feed Product Code: B2-70072-F
Reason: Administration sets assembled with inverted pinch clamp cause the fluid from the distal end of the administration set to be pumped to the proximal end of the tubing when secondary ...
Z-2059-2019July 31, 2019Natick, MA
CareFusion 303, Inc.
Class ITerminated
Alaris Pump, Model 8100, with bezel mechanical assemblies manufactured with FR-110 plastic resin. The following products are affected by this recall as they are pumps or pump assemblies with bezels...
Reason: The bezel manufacturing process for the FR-110 plastic may have resulted in its weakening. A bezel with weakened plastic may, over time, lead to separation of the bezel post (reca...
Z-1768-2019July 24, 2019San Diego, CA
Philips North America, LLC
Class IIITerminated
Philips Patient Information Center iX configured with a regional setting which uses a comma for a decimal separator: 866389 Patient Information Center iX B.01 (or later); 866390 Patient Information ...
Reason: Infusion Pump Data Storage Accuracy-Data from the BBraun Space LAN or Arcomed UniqueDoc infusion pumps transmitted via the HL7 output interface through the Patient Information Cen...
Z-1771-2019June 19, 2019Andover, MA
Philips North America, LLC
Class IIITerminated
Philips IntelliBridge System configured with a regional setting which uses a comma for a decimal separator: 866417 IntelliBridge System C.01 (or later) 866418 IntelliBridge System C.01 upgrade (or...
Reason: Infusion Pump Data Storage Accuracy-Data from the BBraun Space LAN or Arcomed UniqueDoc infusion pumps transmitted via the HL7 output interface through the Patient Information Cen...
Z-1772-2019June 19, 2019Andover, MA
Baxter Healthcare Corporation
Class IITerminated
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), product code 35700BAX - Product Usage: The Baxter SIGMA Spectrum Infusion Pump with Master Drug Library is intended to be used...
Reason: The flow rate test verification was not properly executed for certain Sigma Spectrum infusion pumps prior to release. The testing was performed for less than the required minimum r...
Z-1248-2019May 8, 2019Medina, NY
CareFusion 303, Inc.
Class IITerminated
Alaris Infusion Pump administration sets labeled as: -Infusion Set Alaris Pump Module/Medley Pump Module/Gemini Infusion Pump, REF 10011301, CareFusion, WARNING: TO PREVENT FREE-FLOW, CLOSE SET CLA...
Reason: Complaints where users were unable to prime the administration set.
Z-0385-2019November 14, 2018San Diego, CA
Fresenius Vial Sa
Class IITerminated
Volumat MC Agilia Volumetric Infusion Pump, Model No. Z021135, Software version 1.7. Product Usage - The Volumat MC Agilia is a piece of transportable medical equipment intended to be used in healthca...
Reason: Fresenius Kabi initiated a mandatory software upgrade of the Volumat MC Agilia Volumetric Infusion Pump because it was designed to improve customer experience while preventing comm...
Z-0362-2019November 7, 2018Brezins, N/A
Cardiovascular Systems Inc
Class IITerminated
CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Number: 7-10014, Model Number: SIP-3000. Product Usage: Usage: The pump is a component of the OAS that provides the pump...
Reason: The pumps may switch to stand-by during use requiring the pump to be reset prior to continuing treatment.
Z-3021-2018September 19, 2018Saint Paul, MN
Smiths Medical ASD Inc.
Class IITerminated
Medfusion Syringe Infusion Pump, containing the Barrel Clamp Guide mechanism
Reason: Certain Barrel Clamp Guides may contain a ridge that could potentially lead to spring slippage, resulting in the inability of the pump to recognize a loaded syringe or the pump, mi...
Z-2662-2018August 15, 2018Minneapolis, MN
Baxter Healthcare Corporation
Class IITerminated
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), infusion pump, 35700BAX and 35700ABB Product Usage: The Baxter SIGMA Spectrum Infusion Pump with Master Drug Library is in...
Reason: The firm will be updating the Instructions for Use for the product. Current IFUs instruct users to lower the primary bag 20 inches below the secondary bag using a hanger when perfo...
Z-2112-2018June 13, 2018Medina, NY
Baxter Healthcare Corporation
Class IITerminated
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), infusion pump, 35700BAX2 Product Usage: The Baxter SIGMA Spectrum Infusion Pump with Master Drug Library is intended to be...
Reason: The firm will be updating the Instructions for Use for the product. Current IFUs instruct users to lower the primary bag 20 inches below the secondary bag using a hanger when perfo...
Z-2113-2018June 13, 2018Medina, NY
Baxter Healthcare Corporation
Class IITerminated
Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 35700BAXRE 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-1667-2018May 16, 2018Medina, NY
Baxter Healthcare Corporation
Class IITerminated
Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 35700BAXR Product Usage: The Baxter Sigma Spectrum Infusion Pump with master Drug Library is intended to be used for the co...
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-1665-2018May 16, 2018Medina, NY
Baxter Healthcare Corporation
Class IITerminated
Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6) 35700BAX Product Usage: The Baxter Sigma Spectrum Infusion Pump with master Drug Library is intended to be used for the con...
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-1663-2018May 16, 2018Medina, NY
Baxter Healthcare Corporation
Class IITerminated
Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6) 35700BAXL Product Usage: The Baxter Sigma Spectrum Infusion Pump with master Drug Library is intended to be used for the co...
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...