510(k) K060806 ยท FRN Pump, Infusion
HOSPIRA GEMSTAR INFUSION PUMP SYSTEM, 7 THERAPY, MODEL 13087; 6 THERAPY, MODEL 13086; PAIN MANAGEMENT, MODEL 13088
| Applicant | Hospira, Inc., Lake Forest IL, US |
| Decision | Substantially Equivalent, Apr 21, 2006 |
| Received | Mar 24, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K060806
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 24, 2014 | Hospira 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 |
FRN | None listed |
| Nov 24, 2014 | Hospira 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 |
FRN | None listed |
| Oct 24, 2014 | Hospira 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 |
FRN | None listed |
| Oct 24, 2014 | Hospira 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 |
FRN | None listed |
| Jul 10, 2014 | Hospira 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 |
FRN | None listed |
| May 1, 2014 | Hospira 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 |
FRN | None listed |
| Nov 21, 2013 | Hospira 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 |
FRN | None listed |
| Apr 30, 2013 | Hospira 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 |
FRN | None listed |
| Apr 26, 2013 | Hospira 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 |
FRN | None listed |
| Apr 26, 2013 | Hospira 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 |
FRN | None listed |
| Apr 15, 2013 | Hospira 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 |
FRN | None listed |
| Apr 15, 2013 | Hospira 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 |
FRN | None listed |
| Apr 26, 2012 | Hospira 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 |
FRN | None listed |
| Sep 29, 2010 | Hospira 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 |
FPA | None listed |
| Sep 29, 2010 | Hospira 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 |
FPA | None listed |
| Sep 29, 2010 | Hospira 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 |
FPA | None listed |
| Sep 29, 2010 | Hospira 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 |
FPA | None listed |
| Sep 29, 2010 | Hospira 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 |
FPA | None listed |
| Sep 29, 2010 | Hospira 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 |
FPA | None listed |
| Sep 29, 2010 | Hospira 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 |
FPA | None listed |
| Apr 15, 2010 | Hospira 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 |
FPA | None listed |
| Apr 15, 2010 | Hospira 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 |
FPA | None listed |
| Apr 15, 2010 | Hospira 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 |
FPA | None listed |
| Oct 6, 2009 | Hospira 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 |
FRN | None listed |
| Oct 6, 2009 | Hospira 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 |
FRN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.