FDA Device recall Z-0385-2019
Alaris Infusion Pump administration sets labeled as: -Infusion Set Alaris Pump Module/Medley Pump Module/Gemini Infusion Pump, REF 10011301…
- FDA Device
- Class II
- terminated
- Published 2018-11-14
On 2018-11-14 the FDA classified a Class II recall of Alaris Infusion Pump administration sets labeled as: -Infusion Set Alaris Pump Module/Medley Pump Module/Gemini Infusion Pump, REF 10011301… by Carefusion 303, citing complaints where users were unable to prime the administration set.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0385-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-04-20 |
| Published | 2018-11-14 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Carefusion 303 |
| Distribution | US |
Product
Alaris Infusion Pump administration sets labeled as: -Infusion Set Alaris Pump Module/Medley Pump Module/Gemini Infusion Pump, REF 10011301, CareFusion, WARNING: TO PREVENT FREE-FLOW, CLOSE SET CLAMP WHEN SAFETY CLAMP FITMENT ON PUMP SEGMENT IS OPEN, Fluid path is STERILE and NONPYROGENIC. 12276678 Rev 00 -VersaSafe Infusion Set Alaris Pump Module/Medley Pump Module/Gemini Infusion Pump, REF 2120-0500, WARNING: TO PREVENT FREE-FLOW, CLOSE SET CLAMP WHEN SAFETY CLAMP ON PUMP SEGMENT IS OPEN. FLUID PATH IS STERILE and NON-PYROGENIC. PRODUCT is sterilized by GAMMA IRRADIATION. CareFusion, 630-01104 Rev 00 -SmartSite Infusion Set Alaris Pump Module/Medley Pump Module/Gemini Infusion Pump REF 2420-0500,WARNING: TO PREVENT FREE-FLOW, CLOSE SET CLAMP WHEN SAFETY CLAMP ON PUMP SEGMENT IS OPEN. FLUID PATH IS STERILE and NON-PYROGENIC. PRODUCT is sterilized by GAMMA IRRADIATION. CareFusion, 630-00952 Rev 01 -Infusion Set Alaris Pump Module/Medley Pump Module REF 24009-0007T, WARNING: TO PREVENT FREE-FLOW, CLOSE SET CLAMP WHEN SAFETY CLAMP ON PUMP SEGMENT IS OPEN, FLUID PATH IS STERILE and NON-PYROGENIC. PRODUCT is sterilized by GAMMA IRRADIATION. CareFusion 630-00650 Rev 00 Production Usage: Administration sets allow for the intravenous administration of fluids, medications, nutritional support and transfusion therapy through a needle or catheter inserted into the patient s artery or vein. The sets are comprised with components commonly found on intravascular administration sets and extension sets. The components include an Alaris Pump module silicone segment and fitments, drip chamber, check valve, one or more SmartSite needleless connectors, slide clamp, male luer with spin lock and tubing with different length of tubing.
Reason
Complaints where users were unable to prime the administration set.
Identifiers
| code_info | January 2017 to March 2018 (Lot number format YYMMXXXX). For example 17011234 was manufactured in January 2017 Model…January 2017 to March 2018 (Lot number format YYMMXXXX). For example 17011234 was manufactured in January 2017 Model Codes SKU Description 10011301 AS LVP 20D DEHP YELLOW MICROBORE CV Lot Numbers: 17117241 17117057 17105892 17097208 17096913 17096125 17076873 17067589 17056330 17046330 17037328 17026902 17026332 17025729 17025596 17016349 10011462 AS LVP 60D DEHP 4VS CV Lot Numbers: 18025365 17116358 17046689 17046553 17035030 17025599 17017620 17016350 10012144 AS LVP 20D DEHP 3SS CV Lot Numbers: 18037198 18037197 18037116 18037020 18037019 18036874 18036873 18036872 18036871 18036788 18036635 18036636 18036634 18036599 18036600 18036596 18036595 18036436 18036437 18036435 18036340 18036339 18036099 18036098 18035928 18035927 18035926 18035765 18035764 18026962 18026863 18026862 18026837 18026751 18026752 18026640 18026641 18026642 18026579 18026578 18026468 18 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0385-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.