Zevex, Inc.
Salt Lake City, UT, US
ZEVEX, INC. appears in FDA device records in Salt Lake City, UT. FDA records list 5 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 73 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
4 namesFDA records resolved to Zevex, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- MOOG Medical Devices Groupenforcement report, recall
- Zevex Incorporated (dba MOOG Medical Devices Group)enforcement report, recall
- Zevex Incorporated (dba Moog Medical Medical Devices Group)enforcement report, recall
- Zevex International, Inc.recall
510(k) clearance history
FDA records hold 5 510(k) clearances for Zevex, Inc. between 2001 and 2024. The busiest year on record is 2024, with 2. The most recent is 2024, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2001 | 1 |
| 2014 | 1 |
| 2015 | 1 |
| 2024 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K242660 | Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-series Administration Sets | FRN | Substantially Equivalent | |
| K232793 | Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-Series Adminstration Sets | FRN | Substantially Equivalent | |
| K142539 | EnteraLite Infinity Enteral Pump Delivery Set, 1200 mL Enteral Feeding Delivery Set | PIF | Substantially Equivalent | |
| K131154 | ENTERALITE INFINITY SPIKE ENTERAL DELIVERY SET; ENTERALITE INFINITY 500 ML BAG ENTERAL DELIVERY SET; | LZH | Substantially Equivalent | |
| K012147 | DEVICE MODIFICATION OF ENTERAL FEEDING SETS FOR GRAVITY AND PUMP USE | KNT | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1722139 | 1000117172 | ZEVEX, INC. | 4314 ZEVEX PARK LN., Salt Lake City, UT 84123 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KYGDevice, Irrigation, Ocular Surgery
- PIFGastrointestinal Tubes With Enteral Specific Connectors
- LFLInstrument, Ultrasonic Surgical
- HQEInstrument, Vitreous Aspiration And Cutting, Ac-Powered
- LBKNeurosurgical Ultrasonic Instruments
- FRNPump, Infusion
- LZHPump, Infusion, Enteral
- FPASet, Administration, Intravascular
- KNTTubes, Gastrointestinal (And Accessories)
- HQCUnit, Phacofragmentation
Recall records
Showing 25 of 73| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2054-2019 | 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 name on the label is ZEVEX, Inc., Salt Lake City, UT. | Administration sets leaked at the filter. | Class II | Terminated | |
| Z-2053-2019 | 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 be used with the Moog Curlin Infusion Pump. The pump can be used for intravenous, intra-arterial, epidural, subcutaneous, or enteral infusions. | Administration sets leaked at the filter. | Class II | Terminated | |
| Z-0702-2018 | 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 included for Free Flow Protection, packaged 20/box, for use with the Moog Curlin Ambulatory Volumetric Infusion Pump, RX, Sterile. Product Usage: Administration set to be used with the Moog Curlin infusion Pump. The pump can be used for intravenous, intra-arterial, epidural, subcutaneous, or enteral infusions. | Particulate found on the Curlin spike. | Class II | Terminated | |
| Z-0701-2018 | 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 Protection, packaged 20/box, for use with the Moog Curlin Ambulatory Volumetric Infusion Pump, RX, Sterile. Product Usage: Administration set to be used with the Moog Curlin infusion Pump. The pump can be used for intravenous, intra-arterial, epidural, subcutaneous, or enteral infusions. | Particulate found on the Curlin spike. | Class II | Terminated | |
| Z-0700-2018 | 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 Curlin Ambulatory Volumetric Infusion Pump, RX, Sterile. Product Usage: Administration set to be used with the Moog Curlin infusion Pump. The pump can be used for intravenous, intra-arterial, epidural, subcutaneous, or enteral infusions. | Particulate found on the Curlin spike. | Class II | Terminated | |
| Z-0699-2018 | 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 Volumetric Infusion Pump, RX, Sterile. Product Usage: Administration set to be used with the Moog Curlin infusion Pump. The pump can be used for intravenous, intra-arterial, epidural, subcutaneous, or enteral infusions. | Particulate found on the Curlin spike. | Class II | Terminated | |
| Z-0698-2018 | 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 Curlin Ambulatory Volumetric Infusion Pump, RX, Sterile. Product Usage: Administration set to be used with the Moog Curlin infusion Pump. The pump can be used for intravenous, intra-arterial, epidural, subcutaneous, or enteral infusions. | Particulate found on the Curlin spike. | Class II | Terminated | |
| Z-0697-2018 | 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, Sterile. Product Usage: Administration set to be used with the Moog Curlin infusion Pump. The pump can be used for intravenous, intra-arterial, epidural, subcutaneous, or enteral infusions. | Particulate found on the Curlin spike. | Class II | Terminated | |
| Z-0688-2016 | 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 CMS, and PainSmart IOD, catalog number 360; and Curlin Pump Calibration Set, catalog number 340-4038. | Moog is recalling Curlin 4000, 6000, and PainSmart Infusion Pumps manufactured or serviced by MMDG between March 18, 2015 and November 6, 2015 because the master pumps used to calibrate them were out of tolerance and may cause an over delivery of medications and solutions at a rate of 1.2 - 6.8% faster than programmed. | Class II | Terminated | |
| Z-0415-2016 | Catalog No. INF0020-A EnteraLite Infinity Enteral Pump Delivery Set with ENFit Connector System and Transitional Stepped Connector (spiked set); Catalog No. INF0500-A - 500ml EnteraLite Infinity Enteral Pump Delivery Set with ENFit Connector System and Transitional Stepped Connector; Catalog No INF1200-A - 1200ml EnteraLite Infinity Enteral Pump Delivery Set with ENFit Connector System and Transitional Stepped Connector; Catalog No GR1200-A 1200ml Enteral Feeding Delivery Set with ENFit Connector System and Transitional Stepped Connector (gravity set). Used to dispense liquid nutrients at a preprogrammed pump or user controlled rate. | Potential for leaking between the purple ENFit connector and the white transitional stepped connector due to cracking or breaking of the purple connector. | Class II | Terminated | |
| Z-0294-2013 | EnteraLite Infinity Enteral Feeding Pump identified with the following list numbers: INFKIT2 and INFORNG. The device is used with disposable PVC administration tubing sets to provide a means for the volumetric delivery of fluids used in enteral applications. The EnteraLite Infinity enteral feeding pump with disposable PVC administration tubing sets and user accessories provide a means for the volumetric delivery of fluids used in enteral applications. | MOOG Medical Devices Group is conducting a voluntary for a limited set of serial numbers of the EnteraLite Infinity and Infinity Orange Small Volume Enteral Feeding Pumps because certain diodes on the PCB assembly may result in insufficient voltage to a portion of the pump resulting in an error 13 message and shutting the pump down entirely. | Class II | Terminated | |
| Z-0764-2013 | Infinity Enteralite Ambulatory Feeding Pumps, List number: INFKIT2 - Addendum to Operator's Manual Product usage: provide a means for the volumetric delivery of fluids used in Enteral applications. | The firm is adding an addendum to the operator's manual for Infinity Enteralite Ambulatory Feeding Pumps pertaining to the Infinite Dose mode and the inability of the Pump to detect air in line. | Class II | Terminated | |
| Z-0072-2013 | ***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 disposable PVC Administration Tubing Sets and user accessories, provide a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and Intravenous applications. | This recall is the same issue for the FDA processed recall initiated by Moog Medical Devices on 1/25/11 which was related to customers reporting unclearable Air-In-Line alarm with specific lot numbers of Curlin Administration Sets used with Curlin Ambulatory Infusion Pumps. The lots associated with this recall were inadvertently omitted from the original recall which has since been terminated by | Class II | Terminated | |
| Z-1672-2012 | 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 disposable PVC Administration Tubing Sets and user accessories, provide a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and Intravenous applications. | Moog Medical Device Group became aware on March 23, 2011 via customer complaint, of a reversed pump segment on an Administration Set. This malfunction could reverse the flow of fluid or medication backwards from what was intended. | Terminated | ||
| Z-1671-2012 | 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 Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories, provide a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and Intravenous applications. | Moog Medical Device Group became aware on March 23, 2012 via customer complaint, of a reversed pump segment on an Administration Set. This malfunction could reverse the flow of fluid or medication backwards from what was intended. | Terminated | ||
| Z-1670-2012 | 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 disposable PVC Administration Tubing Sets and user accessories, provide a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and Intravenous applications. | Moog Medical Device Group became aware on March 23, 2012 via customer complaint, of a reversed pump segment on an Administration Set. This malfunction could reverse the flow of fluid or medication backwards from what was intended. | Terminated | ||
| Z-1669-2012 | 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 disposable PVC Administration Tubing Sets and user accessories, provide a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and Intravenous applications. | Moog Medical Device Group became aware on March 23, 2012 via customer complaint, of a reversed pump segment on an Administration Set. This malfunction could reverse the flow of fluid or medication backwards from what was intended. | Terminated | ||
| Z-1668-2012 | 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. | Moog Medical Device Group became aware on March 23, 2012 via customer complaint, of a reversed pump segment on an Administration Set. This malfunction could reverse the flow of fluid or medication backwards from what was intended. | Terminated | ||
| Z-1667-2012 | 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 Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories, provide a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and Intravenous applications. | Moog Medical Device Group became aware on March 23, 2012 via customer complaint, of a reversed pump segment on an Administration Set. This malfunction could reverse the flow of fluid or medication backwards from what was intended. | Terminated | ||
| Z-1666-2012 | 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 Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories, provide a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and Intravenous applications. | Moog Medical Device Group became aware on March 23, 2012 via customer complaint, of a reversed pump segment on an Administration Set. This malfunction could reverse the flow of fluid or medication backwards from what was intended. | Terminated | ||
| Z-1665-2012 | 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 with disposable PVC Administration Tubing Sets and user accessories, provide a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and Intravenous applications. | Moog Medical Device Group became aware on March 23, 2012 via customer complaint, of a reversed pump segment on an Administration Set. This malfunction could reverse the flow of fluid or medication backwards from what was intended. | Terminated | ||
| Z-1664-2012 | 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 disposable PVC Administration Tubing Sets and user accessories, provide a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and Intravenous applications. | Moog Medical Device Group became aware on March 23, 2012 via customer complaint, of a reversed pump segment on an Administration Set. This malfunction could reverse the flow of fluid or medication backwards from what was intended. | Terminated | ||
| Z-1663-2012 | 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 with disposable PVC Administration Tubing Sets and user accessories, provide a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and Intravenous applications. | Moog Medical Device Group became aware on March 23, 2012 via customer complaint, of a reversed pump segment on an Administration Set. This malfunction could reverse the flow of fluid or medication backwards from what was intended. | Terminated | ||
| Z-1662-2012 | 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 disposable PVC Administration Tubing Sets and user accessories, provide a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and Intravenous applications. | Moog Medical Device Group became aware on March 23, 2012 via customer complaint, of a reversed pump segment on an Administration Set. This malfunction could reverse the flow of fluid or medication backwards from what was intended. | Terminated | ||
| Z-1661-2012 | 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 with disposable PVC Administration Tubing Sets and user accessories, provide a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and Intravenous applications. | Moog Medical Device Group became aware on March 23, 2012 via customer complaint, of a reversed pump segment on an Administration Set. This malfunction could reverse the flow of fluid or medication backwards from what was intended. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain