510(k) K042405 ยท FRN Pump, Infusion
PAINPUMP1; PAINPUMP2
| Applicant | Stryker Corp., Kalamazoo MI, US |
| Decision | Substantially Equivalent, Oct 14, 2004 |
| Received | Sep 3, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042405
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 20, 2010 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump2 250 mL Painpump with Luer Lock Tubing Set, REF 525-350, Sterile, Rx only, Stryker Instruments, Kalamazoo, MI. Terminated |
FRN | None listed |
| Sep 28, 2010 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump2 250 mL PainPump with Luer Lock Tubing Set, sterile, REF 525-350, Stryker Instruments, Kalamazoo, MI.
Delivers controlled amounts of medication and narcotics. Terminated |
FRN | None listed |
| Sep 28, 2010 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump2 400 mL PainPump with Luer Lock Tubing Set, sterile, REF 540-350, Stryker Instruments, Kalamazoo, MI.
Delivers controlled amounts of medication and narcotics. Terminated |
FRN | None listed |
| Sep 28, 2010 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump2 BlockAid 400 mL PainPump for Continuous Nerve Block, sterile, REF 575-100, Stryker Instruments, Kalamazoo, MI.
Delivers controlled amounts of medication and narcotics. Terminated |
FRN | None listed |
| Sep 28, 2010 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump2 BlockAid Demo 400 mL PainPump for Continuous Nerve Block, Non-sterile Not for surgical use, REF 575-100S1, Stryker Instruments, Kalamazoo, MI.
Delivers controlled amounts of medi Terminated |
FRN | None listed |
| Aug 19, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump catheter and split introducer needle, sterile, Stryker Instruments, Kalamazoo, MI; REF 500-23. Terminated |
FRN | None listed |
| Aug 19, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker ExFen 2.5" extended fenestration catheter set for PainPump, sterile, Stryker Instruments, Kalamazoo, MI; REF 500-25. Terminated |
FRN | None listed |
| Aug 19, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker ExFen 5.0" extended fenestration catheter set for PainPump, sterile, Stryker Instruments, Kalamazoo, MI; REF 500-50. Terminated |
FRN | None listed |
| Aug 19, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump base kit, 120 mL infusion kit, sterile, Stryker Instruments, Kalamazoo, MI; REF 500-100. Terminated |
FRN | None listed |
| Aug 19, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump, 5-day infusion kit, 120 mL infusion kit (0.83 mL/hr), sterile, Stryker Instruments, Kalamazoo, MI; REF 500-110. Terminated |
FRN | None listed |
| Aug 19, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump, 2-day infusion kit, 120 mL infusion kit (2.08 mL/hr), sterile, Stryker Instruments, Kalamazoo, MI; REF 500-120. Terminated |
FRN | None listed |
| Aug 19, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump, 2-day infusion kit with ExFen 2.5", 120 mL infusion kit (2.08 mL/hr), sterile, Stryker Instruments, Kalamazoo, MI; REF 500-120-25. Terminated |
FRN | None listed |
| Aug 19, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump, 2-day infusion kit with ExFen 5.0", 120 mL infusion kit (2.08 mL/hr), sterile, Stryker Instruments, Kalamazoo, MI; REF 500-120-50. Terminated |
FRN | None listed |
| Aug 19, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump, 1-day infusion kit, 120 mL infusion kit (4.16 mL/hr), sterile, Stryker Instruments, Kalamazoo, MI; REF 500-140. Terminated |
FRN | None listed |
| Aug 19, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump, two site infusion kit with ExFen 2.5", 120 mL infusion kit, sterile, Stryker Instruments, Kalamazoo, MI; REF 500-166-25. Terminated |
FRN | None listed |
| Aug 19, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump, two site infusion kit with ExFen 5.0", 120 mL infusion kit, sterile, Stryker Instruments, Kalamazoo, MI; REF 500-166-50. Terminated |
FRN | None listed |
| Aug 19, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump, two site infusion set, sterile, Stryker Instruments, Kalamazoo, MI; REF 500-200. Terminated |
FRN | None listed |
| Aug 19, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump, two site infusion set, sterile, Stryker Instruments, Kalamazoo, MI; REF 500-250. Terminated |
FRN | None listed |
| Aug 19, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump, 270 mL base infusion kit, sterile, Stryker Instruments, Kalamazoo, MI; REF 0501-100-000. Terminated |
FRN | None listed |
| Aug 19, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump, 270 mL infusion kit (2.08 mL/hr), sterile, Stryker Instruments, Kalamazoo, MI; REF 0501-120-000. Terminated |
FRN | None listed |
| Aug 19, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump, 270 mL infusion kit (4.16 mL/hr), sterile, Stryker Instruments, Kalamazoo, MI; REF 0501-140-000. Terminated |
FRN | None listed |
| Aug 19, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump, 270 mL infusion kit (4.16 mL/hr) with ExFen 2.5", sterile, Stryker Instruments, Kalamazoo, MI; REF 0501-140-025. Terminated |
FRN | None listed |
| Aug 19, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump, 270 mL infusion kit (2.08 cc/hr) with ExFen 5.0", sterile, Stryker Instruments, Kalamazoo, MI; REF 501-140-50. Terminated |
FRN | None listed |
| Aug 19, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump, 270 mL two site infusion kit with ExFen 2.5", sterile, Stryker Instruments, Kalamazoo, MI; REF 0501-416-025. Terminated |
FRN | None listed |
| Aug 19, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump, 270 mL two site infusion kit with ExFen 5.0", sterile, Stryker Instruments, Kalamazoo, MI; REF 0501-416-050. Terminated |
FRN | None listed |
| Aug 19, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump2, 250 mL pre-set PainPump with luer lock tubing set, 2.5 inch ExFen and standard catheter, sterile, Stryker Instruments, Kalamazoo, MI; REF 521-125. Terminated |
FRN | None listed |
| Aug 19, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump2, 250 mL pre-set PainPump with luer lock tubing set, 5.0 inch ExFen and standard catheter, sterile, Stryker Instruments, Kalamazoo, MI; REF 521-155. Terminated |
FRN | None listed |
| Aug 19, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump ExFen, sterile, Stryker Instruments, Kalamazoo, MI; REF 525-10. Terminated |
FRN | None listed |
| Aug 19, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump2, 250 mL PainPump with 2.5 inch ExFen 2-site catheter set, sterile, Stryker Instruments, Kalamazoo, MI; REF 525-25. Terminated |
FRN | None listed |
| Aug 19, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump2, 250 mL PainPump with 5.0 inch ExFen 2-site catheter set, sterile, Stryker Instruments, Kalamazoo, MI; REF 525-50. Terminated |
FRN | None listed |
| Aug 19, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump2, 250 mL PainPump with luer lock tubing set, 2.5 inch ExFen and standard catheter, sterile, Stryker Instruments, Kalamazoo, MI; REF 525-125. Terminated |
FRN | None listed |
| Aug 19, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump2, 250 mL PainPump with luer lock tubing set, 5.0 inch ExFen and standard catheter, sterile, Stryker Instruments, Kalamazoo, MI; REF 525-155. Terminated |
FRN | None listed |
| Aug 19, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump2, 250 mL PainPump with 2.5 inch ExFen catheter and luer lock tubing set, sterile, Stryker Instruments, Kalamazoo, MI; REF 525-156, REF 525-157 and REF 525-158. Terminated |
FRN | None listed |
| Aug 19, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump2, 2-site tube set with standard catheter, sterile, Stryker Instruments, Kalamazoo, MI; REF 525-200-2. Terminated |
FRN | None listed |
| Aug 19, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump2, 2-site tube set with 2.5" ExFens, sterile, Stryker Instruments, Kalamazoo, MI; REF 525-200-25. Terminated |
FRN | None listed |
| Aug 19, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump2, 2-site tube set with 5.0" ExFen, sterile, Stryker Instruments, Kalamazoo, MI; REF 525-200-50. Terminated |
FRN | None listed |
| Aug 19, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump2 ExFen 2.5, 2.5" extended fenestration catheter set for PainPump2, sterile, Stryker Instruments, Kalamazoo, MI; REF 525-250. Terminated |
FRN | None listed |
| Aug 19, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump2 ExFen 2.5, 2.5" catheter set for PainPump2, sterile, Stryker Instruments, Kalamazoo, MI; REF 525-251. Terminated |
FRN | None listed |
| Aug 19, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump2 ExFen 5, 5" extended fenestration catheter set for PainPump2, sterile, Stryker Instruments, Kalamazoo, MI; REF 525-500. Terminated |
FRN | None listed |
| Aug 19, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump2 ExFen 5, 5" catheter set for PainPump2, sterile, Stryker Instruments, Kalamazoo, MI; REF 525-501. Terminated |
FRN | None listed |
| Aug 19, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker standard catheter set for PainPump2 and AutoFuser PainPump, sterile, Stryker Instruments, Kalamazoo, MI; REF 0537-001-000. Terminated |
FRN | None listed |
| Aug 19, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker 5.0 catheter set for PainPump2 and AutoFuser PainPump, sterile, Stryker Instruments, Kalamazoo, MI; REF 0537-005-000. Terminated |
FRN | None listed |
| Aug 19, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker 10.0 catheter set for PainPump2 and AutoFuser PainPump, sterile, Stryker Instruments, Kalamazoo, MI; REF 0537-010-000. Terminated |
FRN | None listed |
| Aug 19, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker 2.5 catheter set for PainPump2 and AutoFuser PainPump, sterile, Stryker Instruments, Kalamazoo, MI; REF 0537-025-000. Terminated |
FRN | None listed |
| Aug 19, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker 5.0 catheter set for PainPump2 and AutoFuser PainPump, sterile, Stryker Instruments, Kalamazoo, MI; REF 0537-205-000. Terminated |
FRN | None listed |
| Aug 19, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker dual 10.0 catheter set for PainPump2 and AutoFuser PainPump, sterile, Stryker Instruments, Kalamazoo, MI; REF 0537-210-000. Terminated |
FRN | None listed |
| Aug 19, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker dual 2.5 catheter set for PainPump2 and AutoFuser PainPump, sterile, Stryker Instruments, Kalamazoo, MI; REF 0537-225-000. Terminated |
FRN | None listed |
| Aug 19, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump2, 400 mL PainPump with 2.5 inch ExFen 2-site catheter set, sterile, Stryker Instruments, Kalamazoo, MI; REF 540-25. Terminated |
FRN | None listed |
| Aug 19, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump2, 400 mL PainPump with 5.0 inch ExFen 2-site catheter set, sterile, Stryker Instruments, Kalamazoo, MI; REF 540-50. Terminated |
FRN | None listed |
| Aug 19, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump2, 400 mL PainPump with luer lock tubing set, 5.0 inch ExFen and standard catheter, sterile, Stryker Instruments, Kalamazoo, MI; REF 540-155. Terminated |
FRN | None listed |
| Aug 19, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump2, 400 mL pre-set PainPump with luer lock tubing set, 5.0 inch ExFen and standard catheter, sterile, Stryker Instruments, Kalamazoo, MI; REF 541-155. Terminated |
FRN | None listed |
| Aug 19, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump, standard antimicrobial silver catheter kit, sterile, Stryker Instruments, Kalamazoo, MI; REF 0555-001-000. Terminated |
FRN | None listed |
| Aug 19, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump ExFen, 2.5 in. antimicrobial silver ExFen catheter kit, sterile, Stryker Instruments, Kalamazoo, MI; REF 0555-002-000. Terminated |
FRN | None listed |
| Aug 19, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump ExFen, 5.0 in. antimicrobial silver ExFen catheter kit, sterile, Stryker Instruments, Kalamazoo, MI; REF 0555-005-000. Terminated |
FRN | None listed |
| Aug 19, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump ExFen, 10.0 in. antimicrobial silver ExFen catheter kit, sterile, Stryker Instruments, Kalamazoo, MI; REF 0555-010-000. Terminated |
FRN | None listed |
| Aug 19, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump ExFen, 2.5 in. dual site antimicrobial silver ExFen catheter, sterile, Stryker Instruments, Kalamazoo, MI; REF 0555-202-000. Terminated |
FRN | None listed |
| Aug 19, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump ExFen, 5.0 in. dual site antimicrobial silver ExFen catheter, sterile, Stryker Instruments, Kalamazoo, MI; REF 0555-205-000. Terminated |
FRN | None listed |
| Aug 19, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump ExFen, 10.0 in. dual site antimicrobial silver ExFen catheter, sterile, Stryker Instruments, Kalamazoo, MI; REF 0555-210-000. Terminated |
FRN | None listed |
| Feb 2, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump, Two Site Infusion Kit with ExFen 2.5", 120 mL Infusion Kit, sterile, 5 per box. Manufactured for Stryker Instruments, Kalamazoo, MI. Product Number 0500-166-025, REF 500-166-25.
A Terminated |
FRN | None listed |
| Feb 2, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump Two Site Infusion Kit with ExFen 5.0", 120 mL Infusion Kit, sterile, 5 per box. Manufactured for Stryker Instruments, Kalamazoo, MI. Product number 0500-166-050, REF 500-166-50.
A d Terminated |
FRN | None listed |
| Feb 2, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump Two Site Infusion Set, sterile, 10 per box. Manufactured for Stryker Instruments, Kalamazoo, MI. Product number 0500-200-000, REF 500-200.
A disposable syringe infuser which uses su Terminated |
FRN | None listed |
| Mar 21, 2006 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump1 Base Kit; Product number 500-100-000. Terminated |
MEA | None listed |
| Mar 21, 2006 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump1 5-Day Infusion Kit ; Product number 500-110-000. Terminated |
MEA | None listed |
| Mar 21, 2006 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump1 2-Day Infusion Kit; Product number 500-120-000. Terminated |
MEA | None listed |
| Mar 21, 2006 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump1 1-Day Infusion Kit; Product number 500-140-000. Terminated |
MEA | None listed |
| Mar 21, 2006 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump1 2-Site Y-Connector; Product number 500-200-000. Terminated |
MEA | None listed |
| Mar 21, 2006 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump1 2-Site Y-Connector; Product number 500-250-000. Terminated |
MEA | None listed |
| Mar 21, 2006 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump1.5 Base Infusion Kit; Product number 501-100-000. Terminated |
MEA | None listed |
| Mar 21, 2006 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump1.5 5-Day Infusion Kit; Product number 501-120-000. Terminated |
MEA | None listed |
| Mar 21, 2006 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump1.5 2-Day Infusion Kit; Product number 501-140-000. Terminated |
MEA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.