FDA Devices recall · Reported March 25, 2015
Medstream 81" (206 cm) 20 drop Universal Administration Sets. Disposable IV infusion set with 3 year expiration date.
Several complaints regarding the IV sets leaking at the Y site.
US Infusion Inc dba Trucare Biomedix-USA recalled Medstream 81" (206 cm) 20 drop Universal Administration Sets. Disposable IV infusion s… - a moderate-severity action.
Medstream 81" (206 cm) 20 drop Universal Administration Sets. Disposable IV infusion s… was recalled by US Infusion Inc dba Trucare Biomedix-USA in March 25, 2015. Reason: Several complaints regarding the IV sets leaking at the Y site.. Check the official notice for the remedy. Verify recall #Z-1277-2015 with the FDA Devices before acting.
The recall
US Infusion Inc dba Trucare Biomedix-USA issued this moderate-severity FDA Devices recall-Several complaints regarding the IV sets leaking at the Y site..
- Moderate
- severity level
- Class II
- classification
- March 25, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1277-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1277-2015) was formally reported on March 25, 2015, with the manufacturer initiating the action on October 10, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. US Infusion Inc dba Trucare Biomedix-USA is listed as the recalling firm, operating out of South Miami, FL. Federal records list the affected scope as 62,700 IV sets.
The documented reason for this recall is: Several complaints regarding the IV sets leaking at the Y site. Distribution data in the federal record shows the product reached: Distributed in the states of TX, IL, MA, OH, CA, and GA.. 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, 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 - 40,861 medical devices recalls on record
Of 88,001 recalls with an agency hazard classification, 19,020 are high severity, 64,468 moderate, and 4,513 low. A further 16,157 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
Medstream 81" (206 cm) 20 drop Universal Administration Sets. Disposable IV infusion set with 3 year expiration date.
Reason for recall
Several complaints regarding the IV sets leaking at the Y site.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1277-2015 |
| Date reported | March 25, 2015 |
| Date initiated | October 10, 2014 |
| Recalling firm | US Infusion Inc dba Trucare Biomedix-USA |
| Firm location | South Miami, FL |
| Affected scope | 62,700 IV sets |
| Distribution | Distributed in the states of TX, IL, MA, OH, CA, and GA. |
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-1277-2015) 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.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. 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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Similar severity · nearest report date
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Methodology · Corrections · Archive as of August 2026