510(k) K882594 ยท FRN Pump, Infusion
THE OMNI-FLOW THERAPIST INFUSION MANAGEMENT SYSTEM
| Applicant | Omni-Flow, Inc., Wilmington MA, US |
| Decision | Substantially Equivalent, Sep 20, 1988 |
| Received | Jun 24, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K882594
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 15, 2010 | Hospira Inc. ColorGard, latex-free, Midlength Secondary I.V. Set, convertible pin, 40 inch with Orange striped tubing for use with OMNI-FLOW and PLUM series infusions systems, 15 drops/mL, a sterile Rx single use Terminated |
FPA | None listed |
| Apr 15, 2010 | Hospira Inc. ColorGard, latex-free, Midlength Secondary I.V. Set, convertible pin, 40 inch with Green striped tubing for use with OMNI-FLOW and PLUM series infusions systems, 15 drops/mL, a sterile Rx single use d Terminated |
FPA | None listed |
| Apr 15, 2010 | Hospira Inc. ColorGard, latex-free, Midlength Secondary I.V. Set, convertible pin, 40 inch with Purple striped tubing for use with OMNI-FLOW and PLUM series infusions systems, 15 drops/mL, a sterile Rx single use Terminated |
FPA | None listed |
| Oct 6, 2009 | Hospira Inc Omniflow 4000 Plus, List numbers 40051-04-05, 40051-04-07, 40051-04-09, 40051-04-51; AC cord manufactured by Electri-Cord, Westfield PA, Infusion pumps manufactured by Hospira, Morgan Hill, CA. Terminated |
FRN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.