CLASS I Device recall · Reported 12 Aug 2020 · FDA Enforcement Report
Alaris Pump Module recalled by CareFusion 303
CareFusion 303 is recalling Alaris Pump Module, distributed in 51 states. The recall was initiated on 30 Jun 2020 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2736-2020
- FDA event ID
- 85954
- Recalling firm
- CareFusion 303, San Diego, CA
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 30 Jun 2020
- FDA classified
- 6 Aug 2020
- Reported
- 12 Aug 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 30 Jun 2020 | Recall initiated by company | |
| 6 Aug 2020 | Classified by FDA | +37 days |
| 12 Aug 2020 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Broken elements on pump module platen such as broken upper hinge post, lower hinge, and membrane frame can occur when the door is forcefully closed on an object, the device is dropped, or if improper cleaners are used on the membrane frame assembly. These may prevent devices from delivering accurate amounts of fluid, which may result in an over infusion, free-flow conditions, or under infusion.
Product as listed by the FDA
Alaris Pump Module Model 8100
Where it was distributed
US: CA, FL, IN, TX, NC, LA, SC, VA, PA, OK, AZ, IL, KY, UT, AL, GA, TN, MA, MI, OH, AK, OR, MS, CO, NY, WI, KS, MO, MD, NV, AR, AS, ID, VT, NE, NJ, DC, HI, CT, MT, WV, NH, WA, DE, ME, NM, MN, WY, IA, SD, ND, MP, PR, GU. OUS: NL, MX, AU, MY, NZ, ZA, GB, FR, CH, CN, SG, TW, CA, IL, KW, QA, DE, BH, IN, SA, GI, AE, PK, PH, BE
AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaDelawareFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusetts
Questions about this recall
Is Alaris Pump Module recalled?
Yes. CareFusion 303 recalled Alaris Pump Module on 30 Jun 2020. The recall is Class I and its status is Terminated. Recall number Z-2736-2020.
Why was it recalled?
Broken elements on pump module platen such as broken upper hinge post, lower hinge, and membrane frame can occur when the door is forcefully closed on an object, the device is dropped, or if improper cleaners are used on the membrane frame assembly. These may prevent devices from delivering accurate amounts of fluid, which may result in an over infusion, free-flow conditions, or under infusion.
Which lots are affected?
All serial numbers
Where was it sold?
US: CA, FL, IN, TX, NC, LA, SC, VA, PA, OK, AZ, IL, KY, UT, AL, GA, TN, MA, MI, OH, AK, OR, MS, CO, NY, WI, KS, MO, MD, NV, AR, AS, ID, VT, NE, NJ, DC, HI, CT, MT, WV, NH, WA, DE, ME, NM, MN, WY, IA, SD, ND, MP, PR, GU. OUS: NL, MX, AU, MY, NZ, ZA, GB, FR, CH, CN, SG, TW, CA, IL, KW, QA, DE, BH, IN, SA, GI, AE, PK, PH, BE
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from CareFusion 303
All 143| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | BD Pyxis MedStation ES Tower recalled by CareFusion 303 | CareFusion 303 | Temperature Abuse | Nationwide |
| Device | CLASS II | BD Pyxis MedBank Mini recalled by CareFusion 303 | CareFusion 303 | Temperature Abuse | Nationwide |
| Device | CLASS II | BD Pyxis MedStation recalled by CareFusion 303 | CareFusion 303 | Temperature Abuse | Nationwide |
| Device | CLASS II | BD Pyxis Anesthesia Station ES recalled by CareFusion 303 | CareFusion 303 | Temperature Abuse | Nationwide |
| Device | CLASS II | BD Pyxis MedStation ES recalled by CareFusion 303 | CareFusion 303 | Temperature Abuse | Nationwide |
Other Other Medical Devices recalls
All 13,778| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Citric Complete Dry Citric Acid Concentrate recalled | Nipro Renal Soultions USA | Other | Nationwide |
| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |