510(k) K002679 ยท FRN Pump, Infusion
6060 MULTI-THERAPY PUMP, MODEL 2M9832; 6060 EPIDURAL PUMP, MODEL 2L9351
| Applicant | Baxter Healthcare Corp, Round Lake IL, US |
| Decision | Substantially Equivalent, Sep 18, 2000 |
| Received | Aug 28, 2000 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K002679
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 28, 2006 | Baxter Healthcare Corp. Baxter 6060 Multi-Therapy Infusion Pump, product codes 2M9832, 2M9832P and 2M9832R, and Sabratek 6060 Homerun Infusion Pumps, product codes 606000, 606000-40, 606000-40L, and 606000-40I; Manufactured Terminated |
FRN | None listed |
| Jan 28, 2006 | Baxter Healthcare Corp. Baxter 6060 Multi-Therapy Infusion Pump, product codes 2M9832, 2M9832P and 2M9832R, and Sabratek 6060 Homerun Infusion Pumps, product codes 606000, 606000-40, 606000-40L, and 606000-40I; Manufactured Terminated |
FRN | None listed |
| Sep 28, 2005 | Baxter Healthcare Corp. Epidural Infusion Pumps sold under the following labels;
a) Baxter 6060E Epidural Infusion Pump, product code 2L9351, 2L9351P and 2L9351R; Manufactured by an affiliate of Baxter Healthcare Corp., Deer Terminated |
FRN | None listed |
| Aug 6, 2005 | Baxter Healthcare Corp. Baxter Sabraset 6060 Administration Set with Pre-attached 250 mL Bag and Cassette, product code 560500-250; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in Mexico Terminated |
FPA | None listed |
| Aug 6, 2005 | Baxter Healthcare Corp. Baxter 6060 Multi-Therapy Infusion Pump, product code 2M9832, 606000-40, 606000-40L, 606000-40I; Manufactured by an affiliate of Baxter Healthcare Corp., Deerfield, IL 60013 USA, made in Singapore Terminated |
FRN | None listed |
| Aug 6, 2005 | Baxter Healthcare Corp. Baxter Sabraset 6060 Administration Set with Pre-attached 100 mL Bag and Cassette, product code 560500-100; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in Mexico Terminated |
FPA | None listed |
| Apr 22, 2005 | Baxter Healthcare Corp. Baxter Lock Box for 100 mL or 250 mL Bag Set, for use with 6060 Pump Family; Baxter product code 2L9354 and previously marketed by Sabratek under product code 606194, Baxter Healthcare Corporation, D Terminated |
FRN | None listed |
| Apr 22, 2005 | Baxter Healthcare Corp. Baxter Lock Box for 250 mL Container, for use with 6060 Pump Family; Baxter product code 2L9363 and previously marketed by Sabratek under product code 606160, Baxter Healthcare Corporation, Deerfield Terminated |
FRN | None listed |
| Jan 8, 2005 | Baxter Healthcare Corp. Baxter labeled 6060 Solution Sets with AutoClamp; For use with model 6060 multi-therapy pumps only; a prescription, sterile, non-pyrogenic fluid pathway; Manufactured by an affiliate of Baxter Healthc Terminated |
FPA | None listed |
| Jan 8, 2005 | Baxter Healthcare Corp. Sabraset Administration Sets with AutoClamp; for use with model 6060 multi-therapy pumps only; a prescription, sterile, non-pyrogenic fluid pathway; Manufactured for Baxter Healthcare Corporation, Dee Terminated |
FPA | None listed |
| Jan 29, 2004 | Baxter Healthcare Corp. Baxter 6060 Multi-Therapy Infusion Pump, product code 2M9832; Manufactured by an affiliate of Baxter Healthcare Corp., Deerfield, IL 60013 USA, made in Singapore Terminated |
FRN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.