15 results
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76ms
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Sources: EU EUDAMED, US FDA
SPECTRUM ASSEMBLY INC.
FDA registration
SPECTRUM ASSEMBLY INC.·3 products·🇺🇸 United States
Plum A+3 Triple Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; the pumps were sold under the following configurations: a) list 12348 - software version 10.3; b) list 12618 - software version 11.3; c) list 20678 - Hospira MedNet software; Product Usage: The Plum A+3 is a dual-line triple channel volumetric infusion system that provides precise delivery of multiple i.v. therapies across the general spectrum of clinical care, including ICU/CCU, OR, PACU, ER, Med/Surg, Pediatrics, Outpatient clinics and Home care
FDA Enforcement
Class II
·Terminated·Hospira Inc.·January 9, 2013
Plum A+ Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; the pumps were sold under the following configurations: a) list 11971; b) list 11973 - software version 10.3; c) list 12391 - software version 11.3; d) list 20679 - Hospira MedNet Software e) list 20792 - Hospira MedNet Software; Product Usage: The Plum A+ Infusion System is a dual-line volumetric infusion pump that provides precise delivery of multiple i.v. therapies across the general spectrum of clinical care, including ICU/CCU, OR, PACU, ER, Med/Surg, Pediatrics, Outpatient clinics and Home care
FDA Enforcement
Class II
·Terminated·Hospira Inc.·January 9, 2013
Plum A+ Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; the pumps were sold under the following configurations: a) list 11971; b) list 11973 - software version 10.3; c) list 12391 - software version 11.3; d) list 20679 - Hospira MedNet Software e) list 20792 - Hospira MedNet Software; Product Usage: The Plum A+ Infusion System is a dual-line volumetric infusion pump that provides precise delivery of multiple i.v. therapies across the general spectrum of clinical care, including ICU/CCU, OR, PACU, ER, Med/Surg, Pediatrics, Outpatient clinics and Home care
FDA Recall
Terminated
·Hospira Inc.·Product code FRN·December 7, 2012
Plum A+3 Triple Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; the pumps were sold under the following configurations: a) list 12348 - software version 10.3; b) list 12618 - software version 11.3; c) list 20678 - Hospira MedNet software; Product Usage: The Plum A+3 is a dual-line triple channel volumetric infusion system that provides precise delivery of multiple i.v. therapies across the general spectrum of clinical care, including ICU/CCU, OR, PACU, ER, Med/Surg, Pediatrics, Outpatient clinics and Home care
FDA Recall
Terminated
·Hospira Inc.·Product code FRN·December 7, 2012
FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
FDA Adverse Event
Injury
·COOK INC·Product code FOZ·September 24, 2018
CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER INC·Product code DYB·April 15, 2024
TECNIS SIMPLICITY
FDA Adverse Event
Malfunction
·AMO PUERTO RICO MFG. INC.·Product code HQL·September 29, 2025
TECNIS IOL
FDA Adverse Event
Malfunction
·AMO PUERTO RICO MFG. INC.·Product code MJP·October 31, 2025
HEALON PRO
FDA Adverse Event
Malfunction
·AMO UPPSALA AB·Product code LZP·October 19, 2025
SMARTLOAD
FDA Adverse Event
Malfunction
·AMO PUERTO RICO MFG. INC.·Product code HQL·December 23, 2025
TECNIS SIMPLICITY
FDA Adverse Event
Malfunction
·AMO PUERTO RICO MFG. INC.·Product code HQL·October 16, 2025
TECNIS SIMPLICITY
FDA Adverse Event
Malfunction
·AMO PUERTO RICO MFG. INC.·Product code HQL·May 1, 2025
SMARTLOAD
FDA Adverse Event
Malfunction
·AMO PUERTO RICO MFG. INC.·Product code HQL·January 30, 2026
WEBSTER CS CATHETER WITH EZ-STEER TECHNOLOGY
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER, INC. (JUAREZ)·Product code DRF·February 15, 2017