Severity
Moderate
FDA Devices recall · Reported September 9, 2015
Sterility may be compromised
Covidien LLC recalled Mahurkar Elite Acute Dual Lumen Catheter Tray, Curved Extensions with IC* Safety Componen… - a moderate-severity action.
Mahurkar Elite Acute Dual Lumen Catheter Tray, Curved Extensions with IC* Safety Componen… was recalled by Covidien LLC in September 9, 2015. Reason: Sterility may be compromised. Check the official notice for the remedy. Verify recall #Z-2532-2015 with the FDA Devices before acting.
The recall
Covidien LLC issued this moderate-severity FDA Devices recall-Sterility may be compromised.
Sourced from official FDA Devices enforcement records. Verify recall #Z-2532-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-2532-2015) was formally reported on September 9, 2015, with the manufacturer initiating the action on August 6, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Covidien LLC is listed as the recalling firm, operating out of North Haven, CT. Federal records list the affected scope as 1 kit.
The documented reason for this recall is: Sterility may be compromised Distribution data in the federal record shows the product reached: US Nationwide Distribution. 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.
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 moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Moderate
Affected scope
1 kit
Related Recalls
6
3 from same agency
Mahurkar Elite Acute Dual Lumen Catheter Tray, Curved Extensions with IC* Safety Components, 12 Fr x 20 cm Item Code: 8888222420 Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular access devices.
Sterility may be compromised
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2532-2015 |
| Date reported | September 9, 2015 |
| Date initiated | August 6, 2015 |
| Recalling firm | Covidien LLC |
| Firm location | North Haven, CT |
| Affected scope | 1 kit |
| Distribution | US Nationwide Distribution |
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.
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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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 September 9, 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.