510(k) K110901 ยท FRN Pump, Infusion
SYMBIQ INFUSION AND ADMINSTRATION SET
| Applicant | Hospira, Inc., Lake Forest IL, US |
| Decision | Substantially Equivalent, Mar 5, 2012 |
| Received | Mar 31, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K110901
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 22, 2015 | Hospira Inc. The Symbiq infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. It is intended primarily for use in the hospital setting and can be used in o Terminated |
FRN | None listed |
| Nov 20, 2013 | Hospira Inc. *** 1) SYMBIQ One-Channel Infuser;
*** 2) SYMBIQ Two-Channel Infuser;
*** E09 batteries can be identified by the "E09" that is printed beneath the bar code and at the end of the serial number along Terminated |
FRN | None listed |
| Aug 1, 2013 | Hospira Inc. The Hospira Symbiq Infusion System is intended for the delivery of fluids, solutions, drugs, agents, nutritionals, electrolytes, blood and blood products via parenteral, enteral, intravenous, intra-ar Terminated |
FRN | None listed |
| Feb 5, 2013 | Hospira Inc. Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids; Product List Number 16026 Terminated |
FRN | None listed |
| Feb 5, 2013 | Hospira Inc. Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids; Product List Number 16027 Terminated |
FRN | None listed |
| 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 |
| 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, nut 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.