510(k) K981816 ยท FRN Pump, Infusion
CUE AMBULATORY VOLUMETRIC INFUSION PUMP
| Applicant | Becton Dickinson Curlin, LLC, Huntington Beach CA, US |
| Decision | Substantially Equivalent, Dec 4, 1998 |
| Received | May 22, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981816
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 23, 2019 | Zevex Incorporated (dba MOOG Medical Devices Group) MOOG Curlin Infusion Administration Set, REF 340-4130, Non-DEHP Tubing with Non-Vented Bag Spike and Vented 0.2 Micron Filter, packaged 20 sets/carton, sterile.
Product Usage:
Administration set to Terminated |
FRN | None listed |
| Jul 23, 2019 | Zevex Incorporated (dba MOOG Medical Devices Group) MOOG Curlin Infusion Administration Set, REF 340-4130-V, Non-DEHP Tubing with Non-Vented Bag Spike and Vented 0.2 Micron Filter with add-on check valve, packaged 20 sets/carton, sterile. The firm nam Terminated |
FRN | None listed |
| Nov 10, 2017 | Zevex Incorporated (dba Moog Medical Medical Devices Group) MOOG Curlin Infusion Administration Set, Ref 340-4114, Non-DEHP Microbore Tubing with Non-Vented Bag Spike, packaged 20/box, for use with the MOOG Curlin Ambulatory Volumetric Infusion Pump, RX, Steri Terminated |
FPA | None listed |
| Nov 10, 2017 | Zevex Incorporated (dba Moog Medical Medical Devices Group) MOOG Curlin Infusion Administration Set, Ref 340-4133, Non-DEHP Microbore Tubing with Non-Vented Bag Spike and Needleless Injection Port (Positive Pressure), packaged 20/box, for use with the Moog Cur Terminated |
FPA | None listed |
| Nov 10, 2017 | Zevex Incorporated (dba Moog Medical Medical Devices Group) MOOG Curlin Infusion Administration Set, Ref 340-4134, Non-DEHP Microbore Tubing with Non-Vented Bag Spike and Y-Site with Check Valve, packaged 20/box, for use with the Moog Curlin Ambulatory Volumet Terminated |
FPA | None listed |
| Nov 10, 2017 | Zevex Incorporated (dba Moog Medical Medical Devices Group) MOOG Curlin Infusion Administration Set, Ref 340-4166, Non-DEHP Microbore Tubing with Non-Vented Spike, Anti-Siphon Valve included for Free Flow Protection, packaged 20/box, for use with the Moog Curl Terminated |
FPA | None listed |
| Nov 10, 2017 | Zevex Incorporated (dba Moog Medical Medical Devices Group) MOOG Curlin Infusion Administration Set, Ref 340-4168, Non-DEHP Microbore Tubing with Non-Vented Bag Spike and distal Female Luer Y-Site with Check Valve, Anti-Siphon Valve included for Free Flow Prot Terminated |
FPA | None listed |
| Nov 10, 2017 | Zevex Incorporated (dba Moog Medical Medical Devices Group) MOOG Curlin Infusion Administration Set, Ref 340-4169, Non-DEHP Microbore Tubing with Non-Vented Bag Spike and distal Ultrasite Needleless Injection Port (Positive Pressure), Anti-Siphon Valve include Terminated |
FPA | None listed |
| Feb 11, 2016 | MOOG Medical Devices Group Moog Curlin Infusion, Ambulatory Infusion Pump
The Curlin Ambulatory Infusion System includes Curlin Ambulatory multi-therapy and PainSmart pumps.
Curlin 4000, catalog number 340; Curlin 6000, 6000 Terminated |
FRN | None listed |
| Oct 17, 2012 | MOOG Medical Devices Group ***This recall is being conducted due to an incomplete recall for RES 57829*** Curlin Infusion Administration Set, REF 340-4165, Sterile EO,
The Curlin Ambulatory Infusion Pump System with disposab Terminated |
FRN | None listed |
| May 30, 2012 | MOOG Medical Devices Group Non-DEHP Microbore Administration Set with Non-Vented Spike Packaged Assembly, product code: 340-4114, Method of Sterilization using Ethylene Oxide.
The Curlin Ambulatory Infusion Pump System with di Terminated |
FPK | None listed |
| May 30, 2012 | MOOG Medical Devices Group Non-DEHP Microbore Administrative Set with Female Luer Adapter Packaged Assembly, product code: 340-4115, Method of Sterilization using Ethylene Oxide.
The Curlin Ambulatory Infusion Pump System with Terminated |
FPK | None listed |
| May 30, 2012 | MOOG Medical Devices Group Epidural Admin Set with Non-Vented Bag Spike and 0.2 Micron Filter Package Assembly, product code: 340-4126, Method of Sterilization using Ethylene Oxide.
The Curlin Ambulatory Infusion Pump System w Terminated |
FPK | None listed |
| May 30, 2012 | MOOG Medical Devices Group Non-DEHP Admin Set with Non-Vented Spike and 1.2 Micron Filter Packaged Assembly, product code: 340-4128, Method of Sterilization using Ethylene Oxide.
The Curlin Ambulatory Infusion Pump System with Terminated |
FPK | None listed |
| May 30, 2012 | MOOG Medical Devices Group Non-DEHP Admin Set with Non-Vented Spike and 1.2 Micron Filter Packaged Assembly, product code: 340-4128-V, Method of Sterilization using Ethylene Oxide.
The Curlin Ambulatory Infusion Pump System wi Terminated |
FPK | None listed |
| May 30, 2012 | MOOG Medical Devices Group Non-DEHP Admin Set with Non-Vented Spike and 0.2 Micron Filter Packaged Assembly, product code: 340-4130, Method of Sterilization using Ethylene Oxide.
The Curlin Ambulatory Infusion Pump System with Terminated |
FPK | None listed |
| May 30, 2012 | MOOG Medical Devices Group Non-DEHP Admin Set with Non-Vented Spike and 0.2 Micron Filter Packaged Assembly, product code: 340-4130-V, Method of Sterilization using Ethylene Oxide.
The Curlin Ambulatory Infusion Pump System wi Terminated |
FPK | None listed |
| May 30, 2012 | MOOG Medical Devices Group Non-DEHP Microbore Admin Set with Female Male Luer Locks and Y-Site with Check Valve Packaged Assembly, product code: 340-4137, Method of Sterilization using Ethylene Oxide.
The Curlin Ambulatory Inf Terminated |
FPK | None listed |
| May 30, 2012 | MOOG Medical Devices Group Non-DEHP Epidural Yellow Striped Tubing Admin Set with Vented Vial Spike and 0.2 Micron Filter Packaged Assembly, product code: 340-4144, Method of Sterilization using Ethylene Oxide.
The Curlin Ambu Terminated |
FPK | None listed |
| May 30, 2012 | MOOG Medical Devices Group Non-DEHP Epidural Admin Set with 0.2 Micron Filter Non-Vented Bag Spike ASV Packaged, product code: 340-4165, Method of Sterilization using Ethylene Oxide. Terminated |
FPK | None listed |
| May 30, 2012 | MOOG Medical Devices Group Non-DEHP Microbore Administration Set with Non-Vented Spike ASV Packaged, product code: 340-4166, Method of Sterilization using Ethylene Oxide.
The Curlin Ambulatory Infusion Pump System with disposa Terminated |
FPK | None listed |
| May 30, 2012 | MOOG Medical Devices Group Non-DEHP Admin Set Non-Vented Spike and 1.2 Micron Filter ASV Packaged Assembly, product code: 340-4173, Method of Sterilization using Ethylene Oxide.
The Curlin Ambulatory Infusion Pump System with Terminated |
FPK | None listed |
| May 30, 2012 | MOOG Medical Devices Group Non-DEHP Microbore Admin Set with Non-Vented Spike and Needleless Injection Port Positive Pressure Package Assembly, product code: 340-4133, Method of Sterilization using Ethylene Oxide.
The Curlin A Terminated |
FPK | None listed |
| May 30, 2012 | MOOG Medical Devices Group Non-DEHP Microbore Administrative Set with Female Luer Adapter Packaged Assembly, product code: 340-4176, Method of Sterilization using Ethylene Oxide.
The Curlin Ambulatory Infusion Pump System with Terminated |
FPK | None listed |
| Apr 13, 2012 | MOOG Medical Devices Group Non-DEHP Microbore Administration Set with Non-Vented Spike Packaged Assembly
The Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories, provide a Terminated |
FRN | None listed |
| Apr 5, 2011 | Zevex International, Inc. Curlin 6000 CMS Ambulatory Infusion Pump
Provides a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and Intravenous applications. Terminated |
FRN | None listed |
| Apr 5, 2011 | Zevex International, Inc. Curlin 6000 IOD Ambulatory Infusion Pump
Provides a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and Intravenous applications. Terminated |
FRN | None listed |
| Apr 5, 2011 | Zevex International, Inc. Curlin PainSmart Ambulatory Infusion Pump
Provides a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and Intravenous applications. Terminated |
FRN | None listed |
| Apr 5, 2011 | Zevex International, Inc. Curlin PainSmart IOD Ambulatory Infusion Pump
Provides a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and Intravenous applications. Terminated |
FRN | None listed |
| Feb 25, 2011 | Zevex International, Inc. ***EXPANDED RECALL*** Curlin Infusion Administration Set, REF 340-4119, Sterile EO, Zevex, Inc., 4314 Zevex Park Lane, Salt Lake City, UT 84123.
The Curlin Ambulatory Infusion Pump System with dispos Terminated |
FRN | None listed |
| Feb 25, 2011 | Zevex International, Inc. ***EXPANDED RECALL*** Curlin Infusion Administration Set, REF 340-4175, Sterile EO, Zevex, Inc., 4314 Zevex Park Lane, Salt Lake City, UT 84123.
The Curlin Ambulatory Infusion Pump System with dispos Terminated |
FRN | None listed |
| Feb 25, 2011 | Zevex International, Inc. ***EXPANDED RECALL*** Curlin Infusion Administration Set, REF 340-4165, Sterile EO, Zevex, Inc., 4314 Zevex Park Lane, Salt Lake City, UT 84123.
The Curlin Ambulatory Infusion Pump System with dispos Terminated |
FRN | None listed |
| Feb 25, 2011 | Zevex International, Inc. Curlin Infusion Administration Set, REF 340-4111, Sterile EO, Zevex, Inc., 4314 Zevex Park Lane, Salt Lake City, UT 84123.
The Curlin Ambulatory Infusion Pump System with disposable PVC Administratio Terminated |
FRN | None listed |
| Feb 25, 2011 | Zevex International, Inc. Curlin Infusion Administration Set, REF 340-4114, Sterile EO, Zevex, Inc., 4314 Zevex Park Lane, Salt Lake City, UT 84123.
The Curlin Ambulatory Infusion Pump System with disposable PVC Administratio Terminated |
FRN | None listed |
| Feb 25, 2011 | Zevex International, Inc. Curlin Infusion Administration Set, REF 340-4115, Sterile EO, Zevex, Inc., 4314 Zevex Park Lane, Salt Lake City, UT 84123.
The Curlin Ambulatory Infusion Pump System with disposable PVC Administratio Terminated |
FRN | None listed |
| Feb 25, 2011 | Zevex International, Inc. Curlin Infusion Administration Set, REF 340-4126, Sterile EO, Zevex, Inc., 4314 Zevex Park Lane, Salt Lake City, UT 84123.
The Curlin Ambulatory Infusion Pump System with disposable PVC Administratio Terminated |
FRN | None listed |
| Feb 25, 2011 | Zevex International, Inc. Curlin Infusion Administration Set, REF 340-4127, Sterile EO, Zevex, Inc., 4314 Zevex Park Lane, Salt Lake City, UT 84123.
The Curlin Ambulatory Infusion Pump System with disposable PVC Administratio Terminated |
FRN | None listed |
| Feb 25, 2011 | Zevex International, Inc. Curlin Infusion Administration Set, REF 340-4128, Sterile EO, Zevex, Inc., 4314 Zevex Park Lane, Salt Lake City, UT 84123.
The Curlin Ambulatory Infusion Pump System with disposable PVC Administratio Terminated |
FRN | None listed |
| Feb 25, 2011 | Zevex International, Inc. Curlin Infusion Administration Set, REF 340-4128-V, Sterile EO, Zevex, Inc., 4314 Zevex Park Lane, Salt Lake City, UT 84123.
The Curlin Ambulatory Infusion Pump System with disposable PVC Administrat Terminated |
FRN | None listed |
| Feb 25, 2011 | Zevex International, Inc. Curlin Infusion Administration Set, REF 340-4130, Sterile EO, Zevex, Inc., 4314 Zevex Park Lane, Salt Lake City, UT 84123.
The Curlin Ambulatory Infusion Pump System with disposable PVC Administratio Terminated |
FRN | None listed |
| Feb 25, 2011 | Zevex International, Inc. Curlin Infusion Administration Set, REF 340-4130-V, Sterile EO, Zevex, Inc., 4314 Zevex Park Lane, Salt Lake City, UT 84123.
The Curlin Ambulatory Infusion Pump System with disposable PVC Administrat Terminated |
FRN | None listed |
| Feb 25, 2011 | Zevex International, Inc. Curlin Infusion Administration Set, REF 340-4134, Sterile EO, Zevex, Inc., 4314 Zevex Park Lane, Salt Lake City, UT 84123.
The Curlin Ambulatory Infusion Pump System with disposable PVC Administratio Terminated |
FRN | None listed |
| Feb 25, 2011 | Zevex International, Inc. Curlin Infusion Administration Set, REF 340-4137, Sterile EO, Zevex, Inc., 4314 Zevex Park Lane, Salt Lake City, UT 84123.
The Curlin Ambulatory Infusion Pump System with disposable PVC Administratio Terminated |
FRN | None listed |
| Feb 25, 2011 | Zevex International, Inc. Curlin Infusion Administration Set, REF 340-4144, Sterile EO, Zevex, Inc., 4314 Zevex Park Lane, Salt Lake City, UT 84123.
The Curlin Ambulatory Infusion Pump System with disposable PVC Administratio Terminated |
FRN | None listed |
| Feb 25, 2011 | Zevex International, Inc. Curlin Infusion Administration Set, REF 340-4162, Sterile EO, Zevex, Inc., 4314 Zevex Park Lane, Salt Lake City, UT 84123.
The Curlin Ambulatory Infusion Pump System with disposable PVC Administratio Terminated |
FRN | None listed |
| Feb 25, 2011 | Zevex International, Inc. Curlin Infusion Administration Set, REF 340-4164, Sterile EO, Zevex, Inc., 4314 Zevex Park Lane, Salt Lake City, UT 84123.
The Curlin Ambulatory Infusion Pump System with disposable PVC Administratio Terminated |
FRN | None listed |
| Feb 25, 2011 | Zevex International, Inc. Curlin Infusion Administration Set, REF 340-4167, Sterile EO, Zevex, Inc., 4314 Zevex Park Lane, Salt Lake City, UT 84123.
The Curlin Ambulatory Infusion Pump System with disposable PVC Administratio Terminated |
FRN | None listed |
| Feb 25, 2011 | Zevex International, Inc. Curlin Infusion Administration Set, REF 340-4168, Sterile EO, Zevex, Inc., 4314 Zevex Park Lane, Salt Lake City, UT 84123.
The Curlin Ambulatory Infusion Pump System with disposable PVC Administratio Terminated |
FRN | None listed |
| Feb 25, 2011 | Zevex International, Inc. Curlin Infusion Administration Set, REF 340-4169, Sterile EO, Zevex, Inc., 4314 Zevex Park Lane, Salt Lake City, UT 84123.
The Curlin Ambulatory Infusion Pump System with disposable PVC Administratio Terminated |
FRN | None listed |
| Feb 25, 2011 | Zevex International, Inc. Curlin Infusion Administration Set, REF 340-4176, Sterile EO, Zevex, Inc., 4314 Zevex Park Lane, Salt Lake City, UT 84123.
The Curlin Ambulatory Infusion Pump System with disposable PVC Administratio Terminated |
FRN | None listed |
| Sep 22, 2008 | Curlin Medical Llc Model 2000 CMS/ Model 2000 Plus Ambulatory Infusion Pump, Model Number: 340-1001 Terminated |
FRN | None listed |
| Sep 22, 2008 | Curlin Medical Llc Model 4000 Plus Ambulatory Infusion Pump, Model Number: 350-1001 Terminated |
FRN | None listed |
| Sep 22, 2008 | Curlin Medical Llc Model 4000 CMS Ambulatory Infusion Pump, Model Number: 350-1101 Terminated |
FRN | None listed |
| Sep 22, 2008 | Curlin Medical Llc Model 6000 CMS, CMS IOD, or Plus Ambulatory Infusion Pump, Model Number: 360-1101 Terminated |
FRN | None listed |
| Sep 22, 2008 | Curlin Medical Llc PainSmart, PainSmart IOD Ambulatory Infusion System, Model Number: 360-1301 Terminated |
FRN | None listed |
| Aug 7, 2007 | Curlin Medical Llc Curlin Medical Administration Sets: Model Numbers 340-4111, IV Administration Sets. Terminated |
FPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.