FDA Devices recall · Reported July 17, 2019
Alaris Pump Infusion Set, Model Codes 10010453, 10010454, 10012144, 10015294, 10015414, 10933805, 11171447, 11404930, 11522558, 11607704, 10013361T, 2110-0500, 2126-0500, 2200-0500, 2411-0500, 2419-0007, 2420-0007, 2420-0500, 2421-0500, 2426-0007, 2426-0500, 2429-0500, 2433-0007, 2477-0000, 2477-0007 2478-0000 C24116E Infusion sets allow for the intravenous administration of fluids, medications, nutritional support and transfusion therapy through a needle or catheter inserted into the patient
An incomplete occlusion can be caused by a variation in the wall thickness of the pumping segment of the affected infusion sets used with the. The issue has the potential to lead…
Becton Dickinson & Company recalled Alaris Pump Infusion Set, Model Codes 10010453, 10010454, 10012144, 10015294, 10015414, 1… - a critical-severity action.
Alaris Pump Infusion Set, Model Codes 10010453, 10010454, 10012144, 10015294, 10015414, 1… was recalled by Becton Dickinson & Company in July 17, 2019. Reason: An incomplete occlusion can be caused by a variation in the wall thickness of the pumping segment of the affe…. Check the official notice for the remedy. Verify recall #Z-1770-2019 with the FDA Devices before acting.
The recall
Becton Dickinson & Company issued this critical-severity FDA Devices recall-An incomplete occlusion can be caused by a variation in the wall thickness of the pumping segment of the affe….
- Critical
- severity level
- Class I
- classification
- July 17, 2019
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1770-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. 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 Infusion Set, Model Codes 10010453, 10010454, 10012144, 10015294, 10015414, 10933805, 11171447, 11404930, 11522558, 11607704, 10013361T, 2110-0500, 2126-0500, 2200-0500, 2411-0500, 2419-0007, 2420-0007, 2420-0500, 2421-0500, 2426-0007, 2426-0500, 2429-0500, 2433-0007, 2477-0000, 2477-0007 2478-0000 C24116E Infusion 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.
Reason for recall
An incomplete occlusion can be caused by a variation in the wall thickness of the pumping segment of the affected infusion sets used with the. The issue has the potential to lead to unintended delivery of medication when the pump module is not in running status or can result in faster than expected drug delivery flow when the pump is infusing.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-1770-2019 |
| Date reported | July 17, 2019 |
| Date initiated | May 6, 2019 |
| Recalling firm | Becton Dickinson & Company |
| Firm location | Franklin Lakes, NJ |
| Affected scope | 17992 lots of Infusion Sets totaling 183,572,651 units (Updated 8/26/19) |
| Distribution | Worldwide Distribution; US (nationwide distribution) to following US states: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, IL, ID, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MP, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA… |
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-1770-2019) 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