Home › Device types › MEB
Pump, Infusion, Elastomeric
FDA product code MEB · Class 2 · General Hospital
926
Registered devices
33,571
Adverse events
109
Recalls
88
510(k) clearances
Devices with this code
SimplFusor — EPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDAmbu® ACTion™ Fuser Pump — Ambu A/SIMed Products — INTEGRATED MEDICAL SYSTEMS, INC.ACTion Fuser Pump, 200ml, 1-6 ml/hrDual 140mm caut-to-size catheter — Ambu A/SMediFlo — NDC HOMECARE LLCMediFlo — NDC HOMECARE LLCACTion Fuser Pump, 400ml, 1-6 ml/hr190mm caut-to-size catheter — Ambu A/SACTion Block Pump, 650ml, 5-15 ml/hr, MultiBolus — Ambu A/SSMARTeZ Pump — EPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDON-Q* Pain Relief System — Avanos Medical, Inc.ON-Q* Pain Relief System — Avanos Medical, Inc.LMA — TELEFLEX INCORPORATEDMcKesson — MCKESSON MEDICAL-SURGICAL INC.Halyard — Avanos Medical, Inc.DOSI-FUSER — LEVENTON SAUON-Q* Pain Relief System — Avanos Medical, Inc.Halyard — Avanos Medical, Inc.DOSI-FUSER — LEVENTON SAUON-Q* Pain Relief System Convenience Kit with Tubing Sets — Avanos Medical, Inc.SimplFusor — EPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDHalyard — Avanos Medical, Inc.Halyard — Avanos Medical, Inc.Halyard — Avanos Medical, Inc.SMARTeZ Pump — EPIC INTERNATIONAL(THAILAND) COMPANY LIMITED
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-05-23 | Leventon S. A. U. | The product lacks 510(k) clearance, and therefore is misbranded and must be removed from the U.S. market. |
| 2018-10-02 | Arrow International Inc | Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a |
| 2018-10-02 | Arrow International Inc | Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a |
| 2018-10-02 | Arrow International Inc | Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a |
| 2018-10-02 | Arrow International Inc | Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a |
| 2018-10-02 | Arrow International Inc | Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a |
| 2018-10-02 | Arrow International Inc | Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a |
| 2018-10-02 | Arrow International Inc | Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a |
| 2018-10-02 | Arrow International Inc | Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a |
| 2018-10-02 | Arrow International Inc | Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a |
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