ClearanceBrief
510(k) K060806 ยท FRN Pump, Infusion

HOSPIRA GEMSTAR INFUSION PUMP SYSTEM, 7 THERAPY, MODEL 13087; 6 THERAPY, MODEL 13086; PAIN MANAGEMENT, MODEL 13088

ApplicantHospira, Inc., Lake Forest IL, US
DecisionSubstantially Equivalent, Apr 21, 2006
ReceivedMar 24, 2006
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K060806

DateFirm and productCodeLinked 510(k)
Nov 24, 2014Hospira Inc.
GemStar infusion pump, list numbers 13000 and 13100, GemStar Infusion Pump (pain management) list number 13150. Product Usage The pump is suitable for intravenous, arterial, subcutaneous, short-term
Terminated
FRNNone listed
Nov 24, 2014Hospira Inc.
GemStar infusion pump, list numbers 13086 and 13087, GemStar infusion pump (pain management) list number 13088. Product Usage The pump is suitable for intravenous, arterial, subcutaneous, short-term
Terminated
FRNNone listed
Oct 24, 2014Hospira Inc.
The GemStar Power Supply is an accessory for the GemStar Infusion Pump. It is a two piece assembled switching power supply. The Power Supply converts alternating current (AC) line input voltage of 120
Terminated
FRNNone listed
Oct 24, 2014Hospira Inc.
The GemStar Power Supply is an accessory for the GemStar Infusion Pump. It is a two piece assembled switching power supply. The Power Supply converts alternating current (AC) line input voltage of 120
Terminated
FRNNone listed
Jul 10, 2014Hospira Inc.
GemStar infusion pump, List numbers 13000 and 13100, GemStar Infusion Pump (pain management) List number 13150. Used for intravenous, arterial, subcutaneous, short-term epidural infusion and
Terminated
FRNNone listed
May 1, 2014Hospira Inc.
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
Terminated
FRNNone listed
Nov 21, 2013Hospira Inc.
The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required. The GemStar Pump can be powered
Terminated
FRNNone listed
Apr 30, 2013Hospira Inc.
The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required. The GemStar Pump can be powered
Terminated
FRNNone listed
Apr 26, 2013Hospira Inc.
GemStar Pump - Battery Product Usage: The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is
Terminated
FRNNone listed
Apr 26, 2013Hospira Inc.
GemStar Pump - Battery Product Usage: The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is r
Terminated
FRNNone listed
Apr 15, 2013Hospira Inc.
The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required. The GemStar Pump can be powered
Terminated
FRNNone listed
Apr 15, 2013Hospira Inc.
The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required. The GemStar Pump can be powered
Terminated
FRNNone listed
Apr 26, 2012Hospira Inc.
GemStar Bolus Cord; a remote bolus cord and switch for use with GemStar 7 Therapy and Pain Management Pumps, list 13000, 13150, 13087 and 13088; Hospira, Inc., Lake Forest, IL 60045; List Number 13027
Terminated
FRNNone listed
Sep 29, 2010Hospira Inc.
Gemstar Pump Set, Latex-Free Extension Set with Integral Pressure-Activated Anti-Siphon Valve and Y-Extension with Backcheck Valve-SL, Nonvented, 110 inch; Rx, sterile, 24 individually packaged sets p
Terminated
FPANone listed
Sep 29, 2010Hospira Inc.
Gemstar Pump Set, Latex-Free Extension Set with Integral Pressure-Activated Anti-Siphon Valve, Yellow Striped Tubing-SL, Nonvented, 110 inch; Rx, sterile, 24 individually packaged sets per case; Hospi
Terminated
FPANone listed
Sep 29, 2010Hospira Inc.
Gemstar Pump Set-SL, Latex-Free Extension Set with Integral Pressure-Activated Anti-Siphon Valve, Nonvented, 96 inch; Rx, sterile, 24 individually packaged sets per case; Hospira, Inc., Lake Forest, I
Terminated
FPANone listed
Sep 29, 2010Hospira Inc.
Gemstar Pump Set-SL, Latex-Free Set with Attached Pressure-Activated Anti-Siphon Valve, Nonvented, 96 inch; Rx, sterile, 24 individually packaged sets per case; Hospira, Inc., Lake Forest, IL 60045 US
Terminated
FPANone listed
Sep 29, 2010Hospira Inc.
Gemstar Pump Set, LifeShield Latex-Free Pump Set with Check Valve, Clave Ports, P.A.V. Secure Lock and Non-DEHP, 59 inch; Rx, sterile, 24 individually packaged sets per case; Hospira, Inc., Lake Fores
Terminated
FPANone listed
Sep 29, 2010Hospira Inc.
Gemstar Pump Set, LifeShield Latex-Free Pump Set with Orange Polyethylene-Lined Light Resistant Tubing, 3 inch Segment of Clear PVC Tubing, 0.2 Micron Filter, Clave Port-SL, Attached Pressure-Activate
Terminated
FPANone listed
Sep 29, 2010Hospira Inc.
Gemstar Pump Set with Convertible Pin, Latex-Free set with Attached Pressure-Activated Anti-Siphon Valve, Pump Yellow Striped Tubing-SL, 95 inch; Rx, sterile, 24 individually packaged sets per case;
Terminated
FPANone listed
Apr 15, 2010Hospira Inc.
Lifeshield, latex-free, MICRO-DRIP, SOLUSET, GEMSTAR 150 ml Burette Pump Set-OL, convertible pin, 110 inch, 60 drops/mL, a sterile Rx single use device, Hospira Inc, Lake Forest, IL USA. Made in Costa
Terminated
FPANone listed
Apr 15, 2010Hospira Inc.
Lifeshield, latex, free, GEMSTAR Primary Piggyback Pump Set-SL, convertible pin, attached pressure-activated anti-siphon valve, 110 inch with 2 CLAVE ports, 15 drops/mL, a sterile Rx single use device
Terminated
FPANone listed
Apr 15, 2010Hospira Inc.
Lifeshield, latex-free, HEMA, GEMSTAR, Y-Type Blood Pump Set, nonvented, 110 inch with CLAVE and OPTION-LOK, 10 drops/mL, a sterile Rx single use device, Hospira Inc, Lake Forest, IL USA. Made in Cost
Terminated
FPANone listed
Oct 6, 2009Hospira Inc
GemStar AC Wall (Mains) adapter, 90-260 volts, universal, list # 13072-04-01, AC cord manufactured by Electri-Cord, Westfield PA, Infusion pumps manufactured by Hospira, Morgan Hill, CA.
Terminated
FRNNone listed
Oct 6, 2009Hospira Inc
GemStar Docking Station (90-260 volts), list numbers 13075-04-01, 13075-04-03, 13075-04-05, 13075-04-07, AC cord manufactured by Electri-Cord, Westfield PA, Infusion pumps manufactured by Hospira, Mor
Terminated
FRNNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.