510(k) K894842 ยท FPA Set, Administration, Intravascular
IMED GEMINI 12 NONVENTED Y-TYPE BLOOD/SOLUTION ADM
| Applicant | Imed Corp., San Diego CA, US |
| Decision | Substantially Equivalent, Sep 12, 1989 |
| Received | Jul 31, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K894842
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 11, 2019 | Becton Dickinson & Company Alaris Pump Infusion Set, Model Codes 10010453, 10010454, 10012144, 10015294, 10015414, 10933805, 11171447, 11404930, 11522558, 11607704, 10013361T, 2110-0500, 2126-0500, 2200-0500, 2411-0500, 2419-00 Terminated |
FPA | None listed |
| Apr 20, 2018 | CareFusion 303, Inc. Alaris Infusion Pump administration sets labeled as:
-Infusion Set
Alaris Pump Module/Medley Pump Module/Gemini Infusion Pump, REF 10011301, CareFusion, WARNING: TO PREVENT FREE-FLOW, CLOSE SET CLAMP Terminated |
FPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.