ClearanceBrief
510(k) K041550 ยท FRN Pump, Infusion

HOSPIRA PHOENIX INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE

ApplicantAbbott Laboratories, Abbott Park IL, US
DecisionSubstantially Equivalent, Jun 30, 2004
ReceivedJun 9, 2004
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K041550

DateFirm and productCodeLinked 510(k)
Feb 4, 2013Hospira Inc.
Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids Device is a general purpose infusion pump designed to deliver fluids, solutions, medications, agents, nutr
Terminated
FRNNone listed
Feb 4, 2013Hospira Inc.
Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids Device is a general purpose infusion pump designed to deliver fluids, solutions, medications, agents, nutr
Terminated
FRNNone listed
Oct 19, 2012Hospira Inc.
Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids; Hospira, Inc., Lake Forest, IL 60045 USA, Made in Costa Rica; List Number 16026-01 Device is a general p
Terminated
FRNNone listed
Oct 19, 2012Hospira Inc.
Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids; Hospira, Inc., Lake Forest, IL 60045 USA, Made in Costa Rica; List Number 16027-01 Device is a general p
Terminated
FRNNone listed
Mar 16, 2011Hospira Inc.
Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids. List number 16026. Note that Hospira retired this pump June 30, 2015. The Hospira Symbiq Infusion Syste
Terminated
FRNNone listed
Mar 16, 2011Hospira Inc.
Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids. List number 16027. Note that Hospira retired this pump June 30, 2015. The Hospira Symbiq Infusion Syste
Terminated
FRNNone listed
Oct 22, 2010Hospira Inc
Hospira brand Symbiq One-Channel Infuser LIST No. 16026 Symbiq One-Channel Infuser, List Number Configurations: 16026-04-01/03/04,51/52, 53/54, 79/80, 81/82, 83/84, 87/88 and 89/90, 16026-13-25/26, 5
Terminated
FRNNone listed
Oct 22, 2010Hospira Inc
Hospira brand Symbiq Two-Channel Infuser, LIST No. 16027 Symbiq Two-Channel Infuser, List Number Configurations: 16027-04-01/03/04, 51/52, 53/54, 79/80,81/82,83/84,87/88 and 89/90 16026-27-89/90, 1
Terminated
FRNNone listed
Sep 9, 2010Hospira Inc
Hospira brand Symbiq One-Channel Infuser LIST No. 16026 Symbiq One-Channel Infuser, List Number Configurations: 16026-04-01/03/04,51/52, 53/54, 79/80, 81/82, 83/84, 87/88 and 89/90, 16026-13-25/26, 5
Terminated
FRNNone listed
Sep 9, 2010Hospira Inc
Hospira brand Symbiq Two-Channel Infuser, LIST No. 16027 Symbiq Two-Channel Infuser, List Number Configurations: 16027-04-01/03/04, 51/52, 53/54, 79/80,81/82,83/84,87/88 and 89/90 16026-27-89/90, 1
Terminated
FRNNone listed
Sep 8, 2010Hospira Inc
Hospira Inc. Symbiq One- and Two- Channel Infuser, List Numbers 16026 and 16027 respectively.
Terminated
FRNNone listed
Jul 2, 2010Hospira Inc
Hospira brand Symbiq One-Channel Infuser; List Number: 16026; Distributed by: Hospira, Inc. Morgan Hill, CA and Manufactured by: Hospira Inc, La Aurora, Heredia, Costa Rica. Intended for the delivery
Terminated
FRNNone listed
Jul 2, 2010Hospira Inc
Hospira brand Symbiq Two-Channel Infuser; List Number: 16027; Distributed by: Hospira, Inc. Morgan Hill, CA and Manufactured by: Hospira Inc, La Aurora, Heredia, Costa Rica. Intended for the delive
Terminated
FRNNone listed
Mar 9, 2010Hospira Inc.
Latex-Free Symbiq Pump Set, convertible pin, 106 inch piggyback with backcheck valve, 2 CLAVE ports, distal microbore tubing and OPTION-LOK, MICRODRIP, non-DEHP 60 drops/mL; a sterile single patient u
Terminated
FPANone listed
Mar 9, 2010Hospira Inc.
Latex-Free Symbiq Pump Set, convertible pin, 106 inch piggyback with backcheck valve, 2 CLAVE ports and OPTION-LOK, 15 drops/mL; a sterile Rx single patient device; Hospira Inc, Lake Forest, IL USA. M
Terminated
FPANone listed
Mar 9, 2010Hospira Inc.
Latex-Free Symbiq Pump Set, convertible pin, 104.5 inch with Polyethylene-Lined tubing, backcheck valve, 2 CLAVE ports, 0.2 micron filter, and OPTION-LOK, piggyback, 15 drops/mL; a sterile Rx device,
Terminated
FPANone listed
Mar 9, 2010Hospira Inc.
Latex-Free Symbiq Pump Set, convertible pin, 106 inch piggyback with backcheck valve, 2 CLAVE ports and OPTION-LOK, non-DEHP, 15 drops/mL; a sterile Rx device; Hospira Inc, Lake Forest, IL USA. Made i
Terminated
FPANone listed
Mar 9, 2010Hospira Inc.
Latex-Free Symbiq Pump Set, convertible pin, 106 inch, piggyback with backcheck valve, 3 CLAVE ports, and OPTION-LOK, non-DEHP, 15 drops/mL; a sterile Rx device; Hospira Inc, Lake Forest, IL USA. Made
Terminated
FPANone listed
Mar 9, 2010Hospira Inc.
Latex-Free Symbiq Pump Set, convertible pin, 104 inch piggyback with backcheck valve, 2 CLAVE ports, 0.2 micron filter and OPTION-LOK, non-DEHP, 15 drops/mL; a sterile Rx device; Hospira Inc, Lake For
Terminated
FPANone listed
Mar 9, 2010Hospira Inc.
Latex-Free Symbiq Pump Set, convertible pin, 106 inch, piggyback with backcheck valve, 3 prepierced injection sites, and OPTION-LOK, non-DEHP, 15 drops/mL; a sterile Rx device; Hospira Inc, Lake Fores
Terminated
FPANone listed
Mar 9, 2010Hospira Inc.
Latex-Free Symbiq Pump Set, convertible pin, 106 inch piggyback with backcheck valve, 2 prepierced injection sites, distal microbore tubing and OPTION-LOK, MICRODRIP, non-DEHP, 60 drops/mL; a sterile
Terminated
FPANone listed
Mar 9, 2010Hospira Inc.
Latex-Free Symbiq Pump Set, convertible pin, 104 inch piggyback with backcheck valve, 2 prepierced injection sites, 0.2 micron filter and OPTION-LOK, non-DEHP, 15 drops/mL; a sterile Rx single use dev
Terminated
FPANone listed
Mar 9, 2010Hospira Inc.
Primary Symbiq Set, Latex-Free with Polyethylene Lined Tubing, 2 CLAVE Y-sites, backcheck valve, 0.2 micron filter, 20 drops/mL; a sterile Rx single use device; Hospira Inc, Lake Forest, IL USA, Hospi
Terminated
FPANone listed
Mar 9, 2010Hospira Inc.
Primary Symbiq Pump Set, 2 CLAVE Y-sites, backcheck valve, 0.2 micron filter, Latex-Free, non-DEHP, 20 drops/mL; a sterile Rx single use device; Hospira Inc, Lake Forest, IL USA, Hospira, Finisklin Bu
Terminated
FPANone listed
Mar 9, 2010Hospira Inc.
Primary Latex-Free Symbiq Pump Set, piggyback with backcheck valve, 2 prepierced Y-sites, 0.2 micron filter, 104 inch, non-DEHP, 15 drops/mL; a sterile Rx single use device; Hospira Inc, Lake Forest,
Terminated
FPANone listed
Mar 9, 2010Hospira Inc.
Primary Symbiq Pump Set, piggyback with backcheck valve, 2 prepierced sites, 105 inch, Latex-Free, non-DEHP, 15 drops/mL; a sterile Rx single use device; Hospira Inc, Lake Forest, IL USA. made in Cost
Terminated
FPANone listed
Mar 9, 2010Hospira Inc.
Latex-Free Primary Symbiq Pump Set, piggyback with backcheck valve, 2 CLAVE Y-sites, 105 inch, non-DEHP, 15 drops/mL; a sterile Rx single use device; Hospira Inc, Lake Forest, IL USA. Made in Costa Ri
Terminated
FPANone listed
Mar 9, 2010Hospira Inc.
Primary Symbiq Set, Latex-Free, Polyethylene-Lined tubing, piggyback with backcheck valve, 2 CLAVE Y-sites, 0.2 micron filter, 104 inch, non-DEHP, 15 drops/mL; a sterile Rx single use device; Hospir
Terminated
FPANone listed
Mar 9, 2010Hospira Inc.
Primary Symbiq Set, Latex-Free piggyback with backcheck valve, 3 prepierced Y-sites, 106 Inch, non-DEHP, 15 drops/mL; a sterile Rx single use device; Hospira Inc, Lake Forest, IL USA. Made in Costa R
Terminated
FPANone listed
Mar 9, 2010Hospira Inc.
Primary Symbiq Set, 2 CLAVE Y-sites, backcheck valve, Latex-Free, non-DEHP, 20 drops/mL; a sterile Rx single use device; Hospira Inc, Lake Forest, IL USA, Hospira, Finisklin Business Park, Sligo, Irel
Terminated
FPANone listed
Mar 9, 2010Hospira Inc.
Primary Symbiq Set, 2 CLAVE Y-sites, backcheck valve, 0.2 micron filter, Latex-Free, non-DEHP, 20 drops/mL; a sterile Rx single use device; Hospira Inc, Lake Forest, IL USA, Hospira, Finisklin Busines
Terminated
FPANone listed
Mar 9, 2010Hospira Inc.
Symbiq Pump Set, detachable, convertible pin piggyback w/backcheck valve, 3 prepierced reseal ports, Option-Lok, Latex-Free, Non-DEHP, 130 in. (330 cm), 15 drops/mL; a sterile Rx single use device; Ho
Terminated
FPANone listed
Feb 22, 2010Hospira Inc.
LifeShield Latex-Free Primary SYMBIQ Set, Piggyback with Backcheck Valve, 3 Prepierced Y-Sites, 106 inch, Non-DEHP, 15 drops/mL; an Rx sterile single use fluid path way for administration of I.V. flui
Terminated
FPANone listed
Aug 11, 2009Hospira Inc
Hospira Phoenix Infusion System with MedNet Software, Symbiq One-Channel Infusion System, Software versions v2.1 & v3.0, Manufactured by Hospira Inc., Morgan Hill, CA.
Terminated
FRNNone listed
Aug 11, 2009Hospira Inc
Hospira Phoenix Infusion System with MedNet Software, Symbiq Two-Channel Infusion System, Software versions v2.1 & v3.0, Manufactured by Hospira Inc., Morgan Hill, CA
Terminated
FRNNone listed
Feb 27, 2009Hospira Inc
Symbiq One-Channel list number 16026-04 and Two-Channel list number 16027-04 Infusion System, a general purpose infuser, Distributed and Manufactured by Hospira Inc, Morgan Hill, CA. Is a general pur
Terminated
FRNNone listed

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