510(k) K010924 ยท FRN Pump, Infusion
MODIFICATION TO PLUM XL INFUSION PUMP
| Applicant | Abbott Laboratories, Abbott Park IL, US |
| Decision | Substantially Equivalent, Apr 6, 2001 |
| Received | Mar 27, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K010924
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 3, 2014 | Hospira Inc. Plum XL, Micro Macro Plum XL3 with data port, and Micro Macro Plum XL with data port infusion pumps, indicated for intravenous, arterial, short-term epidural, and parenteral administration of general Terminated |
FRN | None listed |
| Mar 8, 2011 | Hospira Inc. Hospira Plum XL Micro/Macro with DataPort Infusion Pump, Single Channel, with a 0.1-999 mL/hr flow rate range; list number 11859 Terminated |
FRN | None listed |
| Oct 6, 2009 | Hospira Inc Plum XL, list numbers 11555-04-01, 11555-04-03, 11555-04-05; AC cord manufactured by Electri-Cord, Westfield PA, Infusion pumps manufactured by Hospira, Morgan Hill, CA. Terminated |
FRN | None listed |
| Oct 6, 2009 | Hospira Inc Plum XLD, list numbers 11859-04-01, 11859-04-03, 11859-04-05, 11859-04-07, 11859-04-09, 11859-04-11, 11859-04-13, 11859-04-51, 12570-04-01 (veterinary); AC cord manufactured by Electri-Cord, Westfield Terminated |
FRN | None listed |
| Oct 6, 2009 | Hospira Inc Plum XL 3, list #s 11781-04-01, 11781-04-03, 11781-04-05; AC cord manufactured by Electri-Cord, Westfield PA, Infusion pumps manufactured by Hospira, Morgan Hill, CA. Terminated |
FRN | None listed |
| Oct 6, 2009 | Hospira Inc Plum XL3D, list #s 11855-04-01, 11855-04-03, 11855-04-05, 11855-04-07; 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.