510(k) K041550 ยท FRN Pump, Infusion
HOSPIRA PHOENIX INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE
| Applicant | Abbott Laboratories, Abbott Park IL, US |
| Decision | Substantially Equivalent, Jun 30, 2004 |
| Received | Jun 9, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K041550
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 4, 2013 | Hospira 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 |
FRN | None listed |
| Feb 4, 2013 | Hospira 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 |
FRN | None listed |
| Oct 19, 2012 | Hospira 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 |
FRN | None listed |
| Oct 19, 2012 | Hospira 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 |
FRN | None listed |
| Mar 16, 2011 | Hospira 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 |
FRN | None listed |
| Mar 16, 2011 | Hospira 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 |
FRN | None listed |
| Oct 22, 2010 | Hospira 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 |
FRN | None listed |
| Oct 22, 2010 | Hospira 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 |
FRN | None listed |
| Sep 9, 2010 | Hospira 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 |
FRN | None listed |
| Sep 9, 2010 | Hospira 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 |
FRN | None listed |
| Sep 8, 2010 | Hospira Inc Hospira Inc. Symbiq One- and Two- Channel Infuser, List Numbers 16026 and 16027 respectively. Terminated |
FRN | None listed |
| Jul 2, 2010 | Hospira 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 |
FRN | None listed |
| Jul 2, 2010 | Hospira 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 |
FRN | None listed |
| Mar 9, 2010 | Hospira 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 |
FPA | None listed |
| Mar 9, 2010 | Hospira 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 |
FPA | None listed |
| Mar 9, 2010 | Hospira 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 |
FPA | None listed |
| Mar 9, 2010 | Hospira 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 |
FPA | None listed |
| Mar 9, 2010 | Hospira 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 |
FPA | None listed |
| Mar 9, 2010 | Hospira 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 |
FPA | None listed |
| Mar 9, 2010 | Hospira 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 |
FPA | None listed |
| Mar 9, 2010 | Hospira 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 |
FPA | None listed |
| Mar 9, 2010 | Hospira 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 |
FPA | None listed |
| Mar 9, 2010 | Hospira 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 |
FPA | None listed |
| Mar 9, 2010 | Hospira 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 |
FPA | None listed |
| Mar 9, 2010 | Hospira 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 |
FPA | None listed |
| Mar 9, 2010 | Hospira 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 |
FPA | None listed |
| Mar 9, 2010 | Hospira 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 |
FPA | None listed |
| Mar 9, 2010 | Hospira 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 |
FPA | None listed |
| Mar 9, 2010 | Hospira 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 |
FPA | None listed |
| Mar 9, 2010 | Hospira 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 |
FPA | None listed |
| Mar 9, 2010 | Hospira 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 |
FPA | None listed |
| Mar 9, 2010 | Hospira 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 |
FPA | None listed |
| Feb 22, 2010 | Hospira 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 |
FPA | None listed |
| Aug 11, 2009 | Hospira 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 |
FRN | None listed |
| Aug 11, 2009 | Hospira 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 |
FRN | None listed |
| Feb 27, 2009 | Hospira 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 |
FRN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.