510(k) K041585 ยท MEB Pump, Infusion, Elastomeric
AUTOFUSER AMBULATORY INFUSION PUMP
| Applicant | Algos, LC, Ann Arbor MI, US |
| Decision | Substantially Equivalent, Aug 26, 2004 |
| Received | Jun 14, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K041585
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 4, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker 100 mL AutoFuser PainPump, single site continuous, 1.0 mL/hr, 1 x 2.5" ExFen catheter, sterile, REF 0531-100-025. Infusion pump for pain medication. Terminated |
MEB | None listed |
| Sep 4, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker 100 mL AutoFuser PainPump, single site continuous, 2.0 mL/hr, sterile, REF 0531-200-000. Terminated |
MEB | None listed |
| Sep 4, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker 100 mL AutoFuser PainPump, single site continuous, 2.0 mL/hr, 1 x 2.5" standard catheter, sterile, Manufactured for Stryker Instruments, Kalamazoo, MI; REF 0531-200-001. Terminated |
MEB | None listed |
| Sep 4, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker 100 mL AutoFuser PainPump, single site continuous, 2 mL/hr, 1 x 2.5" catheter, sterile, REF 0531-200-025. Terminated |
MEB | None listed |
| Sep 4, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker 100 mL AutoFuser PainPump, dual site continuous, 2 mL/hr, sterile, REF 0531-200-200. Terminated |
MEB | None listed |
| Sep 4, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker 100 mL AutoFuser PainPump, dual site continuous, 2 mL/hr, 2 x 2.5 in. catheters, sterile, REF 0531-200-250. Terminated |
MEB | None listed |
| Sep 4, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker 100 mL AutoFuser PainPump, single site continuous, 2 mL/hr, 1 mL bolus, 60 minute bolus refill, sterile, REF 0531-216-000. Terminated |
MEB | None listed |
| Sep 4, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker 100 mL AutoFuser PainPump, single site continuous with bolus, 2 mL/hr, 1 mL bolus, 60 minute bolus refill, standard catheter, sterile, ; REF 0531-216-001. Terminated |
MEB | None listed |
| Sep 4, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker 100 mL AutoFuser PainPump, single site continuous with bolus, 2 mL/hr, 1 mL bolus, 60 minute bolus refill, 1 x 2.5 in. catheter, sterile, REF 0531-216-025. Terminated |
MEB | None listed |
| Sep 4, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker 100 mL AutoFuser PainPump, single site continuous with bolus, 2 mL/hr, 1 mL bolus, 60 minute bolus refill, 1 x 5.0 in. catheter, sterile, REF 0531-216-050. Terminated |
MEB | None listed |
| Sep 4, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker 275 mL AutoFuser PainPump, single site continuous, 2 mL/hr, sterile, REF 0532-200-000. Terminated |
MEB | None listed |
| Sep 4, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker 275 mL AutoFuser PainPump, single site continuous, 2 mL/hr,standard catheter, sterile, REF 0532-200-001. Terminated |
MEB | None listed |
| Sep 4, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker 275 mL AutoFuser PainPump, single site continuous, 2 mL/hr, 1 x 2.5 in. catheter, sterile, REF 0532-200-025. Terminated |
MEB | None listed |
| Sep 4, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker 275 mL AutoFuser PainPump, single site continuous, 2 mL/hr, 1 x 5.0 in. catheter, sterile, REF 0532-200-050. Terminated |
MEB | None listed |
| Sep 4, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker 275 mL AutoFuser PainPump, single site continuous, 2 mL/hr, 2 mL bolus, 60 minute bolus refill, sterile, REF 0532-226-000. Terminated |
MEB | None listed |
| Sep 4, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker 275 mL AutoFuser PainPump, single site continuous with bolus, 2 mL/hr, 2 mL bolus, 60 minute bolus refill, 1 x 2.5 in. catheter, sterile, REF 0532-226-025. Terminated |
MEB | None listed |
| Sep 4, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker 275 mL AutoFuser PainPump, single site continuous with bolus, 2 mL/hr, 2 mL bolus, 60 minute bolus refill, 1 x 5.0 in. catheter, sterile, REF 0532-226-050. Terminated |
MEB | None listed |
| Sep 4, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker 275 mL AutoFuser PainPump, dual site continuous, 4 mL/hr, sterile, REF 0532-400-200. Terminated |
MEB | None listed |
| Sep 4, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker 275 mL AutoFuser PainPump, dual site continuous, 4 mL/hr, 2 x 10 in. catheters, sterile, REF 0532-400-210. Terminated |
MEB | None listed |
| Sep 4, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker 275 mL AutoFuser PainPump, dual site continuous, 4 mL/hr, 2 x 2.5 in. catheter, sterile, REF 0532-400-225. Terminated |
MEB | None listed |
| Sep 4, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker 275 mL AutoFuser PainPump, dual site continuous, 4 mL/hr, 2 x 5.0 in. catheters, sterile, REF 0532-400-250. Terminated |
MEB | None listed |
| Sep 4, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker 275 mL AutoFuser PainPump, single site continuous, 5 mL/hr, sterile, REF 0532-500-000. Terminated |
MEB | None listed |
| Sep 4, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker 275 mL AutoFuser PainPump, single site continuous, 5 mL/hr, standard catheter, sterile, REF 0532-500-001. Terminated |
MEB | None listed |
| Sep 4, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker 275 mL AutoFuser PainPump, single site continuous, 5 mL/hr, 1 x 2.5 in. catheter, sterile, REF 0532-500-025. Terminated |
MEB | None listed |
| Sep 4, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker 275 mL AutoFuser PainPump, single site continuous, 5 mL/hr, 1 x 5.0 in. catheter, sterile, REF 0532-500-050. Terminated |
MEB | None listed |
| Sep 4, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker 275 mL AutoFuser PainPump, single site continuous, 5 mL/hr, 2 mL bolus, 60 minute bolus refill, sterile, REF 0532-526-000. Terminated |
MEB | None listed |
| Sep 4, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker 275 mL AutoFuser PainPump, single site continuous, 5 mL/hr, 2 mL bolus, 60 minute bolus refill, 1 x 2.5 in. catheter, sterile, REF 0532-526-025. Terminated |
MEB | None listed |
| Sep 4, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker 275 mL AutoFuser PainPump, single site continuous with bolus, 5 mL/hr, 2 mL bolus, 60 minute bolus refill, 1 x 5.0 in. catheter, sterile, REF 0532-526-050. Terminated |
MEB | None listed |
| Sep 4, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker 550 mL AutoFuser PainPump, single site continuous, 10 mL/hr, sterile, REF 0535-100-000. Terminated |
MEB | None listed |
| Sep 4, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker 550 mL AutoFuser PainPump, dual site continuous, 4 mL/hr, sterile, REF 0535-400-200. Terminated |
MEB | None listed |
| Sep 4, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker 550 mL AutoFuser PainPump, dual site continuous, 4 mL/hr, 2 x 10.0 in. catheters, sterile, REF 0535-400-210. Terminated |
MEB | None listed |
| Sep 4, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker 550 mL AutoFuser PainPump, dual site continuous, 4 mL/hr, 2 x 2.5 in. catheters, sterile, REF 0535-400-225. Terminated |
MEB | None listed |
| Sep 4, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker 550 mL AutoFuser PainPump, dual site continuous, 4 mL/hr, 2 x 5.0 in. catheters, sterile, REF 0535-400-250. Terminated |
MEB | None listed |
| Sep 4, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker 550 mL AutoFuser PainPump, single site continuous with bolus, 4 mL/hr, 2 mL bolus, 60 minute bolus refill, sterile, REF 0535-426-000. Terminated |
MEB | None listed |
| Sep 4, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker 550 mL AutoFuser PainPump, single site continuous with bolus, 4 mL/hr, 2 mL bolus, 60 minute bolus refill, 1 x 10.0 in. catheter, sterile, REF 0535-426-010. Terminated |
MEB | None listed |
| Sep 4, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker 550 mL AutoFuser PainPump, single site continuous with bolus, 4 mL/hr, 2 mL bolus, 60 minute bolus refill, 1 x 2.5 in. catheter, sterile, REF 0535-426-025. Terminated |
MEB | None listed |
| Sep 4, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker 550 mL AutoFuser PainPump, single site continuous with bolus, 4 mL/hr, 2 mL bolus, 60 minute bolus refill, 1 x 5.0 in. catheter, sterile, REF 0535-426-050. Terminated |
MEB | None listed |
| Sep 4, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker 550 mL AutoFuser PainPump, single site continuous with bolus, 5 mL/hr, sterile, REF 0535-500-000. Terminated |
MEB | None listed |
| Sep 4, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker 550 mL AutoFuser PainPump, single site continuous with bolus, 5 mL/hr, 1 x 10.0 in. catheter, sterile, REF 0535-500-010. Terminated |
MEB | None listed |
| Sep 4, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker 550 mL AutoFuser PainPump, single site continuous with bolus, 5 mL/hr, 1 x 5.0 in. catheter, sterile, REF 0535-500-050. Terminated |
MEB | None listed |
| Sep 4, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker 550 mL AutoFuser PainPump, single site continuous with bolus, 6 mL/hr, sterile, REF 0535-600-000. Terminated |
MEB | None listed |
| Sep 4, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker 550 mL AutoFuser PainPump, single site continuous with bolus, 6 mL/hr, 2 mL bolus, sterile, REF 0535-626-000. Terminated |
MEB | None listed |
| Sep 4, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker 550 mL AutoFuser PainPump, single site continuous with bolus, 6 mL/hr, 2 mL bolus, 60 minute bolus refill, 1 x 10.0 in. catheter, sterile, REF 0535-626-010. Terminated |
MEB | None listed |
| Sep 4, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker 550 mL AutoFuser PainPump, single site continuous with bolus, 6 mL/hr, 2 mL bolus, 60 minute bolus refill, 1 x 2.5 in. catheter, sterile, REF 0535-626-025. Terminated |
MEB | None listed |
| Sep 4, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker 550 mL AutoFuser PainPump, single site continuous with bolus, 6 mL/hr, 2 mL bolus, 60 minute bolus refill, 1 x 5.0 in. catheter, sterile, REF 0535-626-050. Terminated |
MEB | None listed |
| Sep 4, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker 100 mL AutoFuser PainPump, single site continuous, 2 mL/hr with 2.5 in. antimicrobial silver ExFen catheter, sterile, REF 8531-200-025. Terminated |
MEB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.