Severity
Critical
CriticalClass ITerminated
FDA Devices recall · Reported August 26, 2015
Alaris Medley LVP Frame Membrane. Intended use to hold platen assembly and help protect the bezel assembly's internal components from fluid intrusion. This part is used in the Alaris Medley LVP 8100 infusion pump.
Administration of inappropriate quantities of fluid can result, with the potential to cause injury or death.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Elite Biomedical Solutions LLC recalled Alaris Medley LVP Frame Membrane. Intended use to hold platen assembly and help protec… - a critical-severity action.
Alaris Medley LVP Frame Membrane. Intended use to hold platen assembly and help protec… was recalled by Elite Biomedical Solutions LLC in August 26, 2015. Reason: Administration of inappropriate quantities of fluid can result, with the potential to cause injury or death.. Check the official notice for the remedy. Verify recall #Z-2371-2015 with the FDA Devices before acting.
The recall
Elite Biomedical Solutions LLC issued this critical-severity FDA Devices recall-Administration of inappropriate quantities of fluid can result, with the potential to cause injury or death..
- Critical
- severity level
- Class I
- classification
- August 26, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2371-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2371-2015) was formally reported on August 26, 2015, with the manufacturer initiating the action on June 3, 2015. It is classified under Critical severity (Class I), with a current status of Terminated. Elite Biomedical Solutions LLC is listed as the recalling firm, operating out of Cincinnati, OH. Federal records list the affected scope as 609 pieces.
The documented reason for this recall is: Administration of inappropriate quantities of fluid can result, with the potential to cause injury or death. Distribution data in the federal record shows the product reached: Nationwide Distribution in the states of AZ, CA, GA, IL, IN, KS, KY, MA, MD, MN, MO, MS, NC, NY, OH, PA, SC, TN, TX, VA & WI.. Distribution scope 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, 3 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 - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. 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.
Affected scope
609 pieces
Related Recalls
6
3 from same agency
Product description
Alaris Medley LVP Frame Membrane. Intended use to hold platen assembly and help protect the bezel assembly's internal components from fluid intrusion. This part is used in the Alaris Medley LVP 8100 infusion pump.
Reason for recall
Administration of inappropriate quantities of fluid can result, with the potential to cause injury or death.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-2371-2015 |
| Date reported | August 26, 2015 |
| Date initiated | June 3, 2015 |
| Recalling firm | Elite Biomedical Solutions LLC |
| Firm location | Cincinnati, OH |
| Affected scope | 609 pieces |
| Distribution | Nationwide Distribution in the states of AZ, CA, GA, IL, IN, KS, KY, MA, MD, MN, MO, MS, NC, NY, OH, PA, SC, TN, TX, VA & WI. |
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-2371-2015) 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.
Frequently Asked Questions
What product was recalled? ▼
Alaris Medley LVP Frame Membrane. Intended use to hold platen assembly and help protect the bezel assembly's internal components from fluid intrusion. This part is used in the Alaris Medley LVP 8100 infusion pump.. Recalled by Elite Biomedical Solutions LLC. Units affected: 609 pieces.
Why was this product recalled? ▼
Administration of inappropriate quantities of fluid can result, with the potential to cause injury or death.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 26, 2015. Severity: Critical. Recall number: Z-2371-2015.
Where was the recalled product distributed? ▼
Distribution: Nationwide Distribution in the states of AZ, CA, GA, IL, IN, KS, KY, MA, MD, MN, MO, MS, NC, NY, OH, PA, SC, TN, TX, VA & WI..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2371-2015) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported August 26, 2015. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.