FDA Devices recall · Reported August 12, 2020
Alaris Pump Module Model 8100
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 dro…
CareFusion 303, Inc. recalled Alaris Pump Module Model 8100 - a critical-severity action.
Alaris Pump Module Model 8100 was recalled by CareFusion 303, Inc. in August 12, 2020. Reason: Broken elements on pump module platen such as broken upper hinge post, lower hinge, and membrane frame can oc…. Check the official notice for the remedy. Verify recall #Z-2736-2020 with the FDA Devices before acting.
The recall
CareFusion 303, Inc. issued this critical-severity FDA Devices recall-Broken elements on pump module platen such as broken upper hinge post, lower hinge, and membrane frame can oc….
- Critical
- severity level
- 1.1M units
- affected scope
- Class I
- classification
- August 12, 2020
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2736-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope (see the Recall Profile below) places it in the million-unit bracket that typically triggers nationwide consumer alerts and retailer sweeps. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
Alaris Pump Module Model 8100
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-2736-2020 |
| Date reported | August 12, 2020 |
| Date initiated | June 30, 2020 |
| Recalling firm | CareFusion 303, Inc. |
| Firm location | San Diego, CA |
| Affected scope | 1093588 |
| Distribution | 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,… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2736-2020) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Critical), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026