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Sources: EU EUDAMED, US FDA
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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 computer systems and Hospira infusion pumps. The MMS provides trained healthcare professionals with the capability to send, receive, report, and store information from interfaced external systems, and to configure and edit infusion programming parameters. The MMS is intended to provide a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data. All data entry and validation of infusion parameters is performed by a trained healthcare professional according to physicians orders.
FDA Enforcement
Class II
·Terminated·Hospira Inc.·July 16, 2014
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 The ICU Medical MedNet Medication Management Suite (MMS) is intended to facilitate networked communication between MMS compatible computer systems and MedNet compatible infusion pumps. The MMS provides trained healthcare professionals with the capability to send, receive, report, and store information from interfaced external systems, and to configure and edit infusion programming parameters. The MMS is intended to provide a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data. All data entry and validation of infusion parameters is performed by a trained healthcare professional according to physician s orders.
FDA Enforcement
Class II
·Terminated·ICU Medical Inc·December 13, 2017
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 computer systems and Hospira infusion pumps. The MMS provides trained healthcare professionals with the capability to send, receive, report, and store information from interfaced external systems, and to configure and edit infusion programming parameters. The MMS is intended to provide a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data. All data entry and validation of infusion parameters is performed by a trained healthcare professional according to physicians orders.
FDA Recall
Terminated
·Hospira Inc.·Product code FRN·June 6, 2014
Medline Custom Open Heart CDS Kit (non-sterile), reorder number CDS840144A, which contains Meridian Nexus Unilimb Rebreathing Circuit, part 40301-1-30, among other components needed for open heart surgery; Made in USA by Medline Industries, Inc., Mundelein, IL 60060
FDA Recall
Terminated
·Medline Industries, Inc.·Product code LRO·March 18, 2005
Medline Custom Anesthesia Circuit 40in Adult Unilimb Kit (non-sterile), reorder number DYNJAA4315; the kit contains the Nexus Adult Unilimb Circuit - 40'', part C4N012100, along with a 3 liter latex breathing bag, adult large anesthesia mask, gas line and poly bag; Made in USA by Medline Industries, Inc., Mundelein, IL 60060
FDA Recall
Terminated
·Medline Industries, Inc.·Product code LRO·March 18, 2005
Medline Custom Anesthesia Circuit 40in Adult Unilimb Kit (non-sterile), reorder number DYNJAAF4304B; the kit contains the Nexus Adult Unilimb Circuit - 40'', part C4N012100, along with a 3 liter latex free breathing bag, gas sampling coestrud and poly bag; Made in USA by Medline Industries, Inc., Mundelein, IL 60060
FDA Recall
Terminated
·Medline Industries, Inc.·Product code LRO·March 18, 2005
Medline Custom Anesthesia Circuit Adult 40in Mask 3L Kit (non-sterile), reorder number DYNJAA4749; the kit contains the Nexus Adult Unilimb Circuit - 40'', part C4N000D001, along with a 3 liter latex free breathing bag, adult medium anesthesia mask and poly bag; Made in USA by Medline Industries, Inc., Mundelein, IL 60060
FDA Recall
Terminated
·Medline Industries, Inc.·Product code LRO·March 18, 2005
CEMIX - CEMENT MIXING SYSTEM, CODE INTV-MMS
FDA Enforcement
Class II
·Terminated·BIOPSYBELL S.R.L.·May 26, 2021
Medline Custom Anesthesia Super Circuit Adult 60 Unilimb Kit (non-sterile), reorder number DYNJAAF6267; the kit contains the Nexus Adult Unilimb Circuit - 60'', part 60010-1B, along with a 3 liter latex breathing bag, anesthesia tubing clip, suction catheter, adult anesthesia mask, suction canister, drawstring poly bag and poly bag; Made in USA by Medline Industries, Inc., Mundelein, IL 60060
FDA Recall
Terminated
·Medline Industries, Inc.·Product code LRO·March 18, 2005
Medline Custom Anesthesia Set Up Kit - Latex Free (non-sterile), reorder number DYNJAA0078C; the kit contains the Nexus Adult Unilimb Circuit - 40'', part C4N000D001, along with a 3 liter latex free breathing bag, suction catheter, adult medium anesthesia mask, suction tubing, humid vent hme filter and poly bag; Made in USA by Medline Industries, Inc., Mundelein, IL 60060
FDA Recall
Terminated
·Medline Industries, Inc.·Product code LRO·March 18, 2005
CEMIX - CEMENT MIXING SYSTEM STERILE, CODE INTV-MMS. For use in Orthopedic / spinal procedures.
FDA Enforcement
Class II
·Terminated·Zavation·June 9, 2021
M3001A Philips Multi Measurement Server (MMS)
FDA Recall
Terminated
·Philips Medical Systems·Product code DQA·September 21, 2006
CEMIX - CEMENT MIXING SYSTEM, CODE INTV-MMS
FDA Recall
Terminated
·BIOPSYBELL S.R.L. Via Aldo Manuzio N. 24 Via A.Manuzio n.24 Mirandola Italy·Product code LOD·March 22, 2021
U3-3 Solar Blue, Laptop integrated power supply used with the Solar Blue Urodynamics for assessing lower urinary tract dysfunctions
FDA Recall
Terminated
·LABORIE MEDICAL TECHNOLOGIES, CORP·Product code FEN·July 17, 2019
IntelliVue MultiMeasurement Server (MMS)/Multimeasurement Server, physiological patient monitoring system. Model: M3001A
FDA Recall
Terminated
·Philips Medical Systems·Product code DQA·July 24, 2006
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 The ICU Medical MedNet Medication Management Suite (MMS) is intended to facilitate networked communication between MMS compatible computer systems and MedNet compatible infusion pumps. The MMS provides trained healthcare professionals with the capability to send, receive, report, and store information from interfaced external systems, and to configure and edit infusion programming parameters. The MMS is intended to provide a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data. All data entry and validation of infusion parameters is performed by a trained healthcare professional according to physician s orders.
FDA Recall
Terminated
·ICU Medical Inc·Product code FRN·October 30, 2017
CEMIX - CEMENT MIXING SYSTEM STERILE, CODE INTV-MMS. For use in Orthopedic / spinal procedures.
FDA Recall
Terminated
·Zavation·Product code NDN·March 25, 2021
Pump Tube Set for MMS Libra and Solar Systems - Product Usage: Intended for use during water perfusion urodynamic procedures to study the function of the bladder and urethra during filling and voiding, by monitoring pressure and pressure changes.
FDA Enforcement
Class II
·Terminated·LABORIE MEDICAL TECHNOLOGIES, CANADA ULC·July 15, 2020
Unilimb Circuit 40'' Bulk, single use Part Number 225-4400-300. Manufactured for MMS Sales Corporation, 218 Highline Road, Pharr, Texas 78577, Made in Mexico.
FDA Recall
Terminated
·MMS Sales Corp·Product code CAI·February 21, 2005
Circuit-Nexus, Adult, single use, Part Numbers: N7A110CG06, N4A100CE06, C4N0121000, 60010-1B, and 40301-1-2730. Manufactured for MMS Sales Corporation, 218 Highline Road, Pharr, Texas 78577, Made in Mexico.
FDA Recall
Terminated
·MMS Sales Corp·Product code CAI·February 21, 2005