Alaris Infusion Pump administration sets labeled as: -Infusion Set… — Class II medical device recall Z-0385-2019
Terminated recall by CareFusion 303, Inc., reported 2018-11-14, distributed nationwide. Complaints where users were unable to prime the administration set.
| Recall number | Z-0385-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | CareFusion 303, Inc., San Diego, CA, United States |
| Recall initiated | 2018-04-20 |
| Classified | 2018-11-03 |
| Reported by FDA | 2018-11-14 |
| Terminated | 2021-02-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, HK, NZ, TW, ZA |
| Quantity | 118,254,342 |
| Lot numbers | 0.2MCV, 10010541-07AS, 10011301AS, 10011462AS, 10012144AS, 10012182AS, 10013034AS, 10013072AS, 10013186AS, 10013361AS, 10013361TAS, 10013889AS, 10014855AAS, 10015104, 10015294AS, 10015312AS, 10015489AS, 10015861AAS, 10015896AS, 10031773AS, 10061661AAS, 10137405AS, 10142568AS, 10178573AS, 10404198AS, 10406194AS, 10408730AS, 10561554AS, 10813621AS, 10817613AS, 10879047AS, 10879391AS, 10927766AS, 10933805AS, 10D, 11059729AS, 11171447AS, 11287205AS, 11404930AS, 11419365AS and 460 more |
| Model numbers | 10011301, 2120-0500, 24009-0007T, 2420-0500 |
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 for recall
Complaints where users were unable to prime the administration set.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.