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Recall Observatory FDA recall evidence

Device product

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.

Z-2532-2015

August 06, 2015

Class II

Product summary

Firm
Covidien LLC
Event
Event 71893
Status
Terminated
Classification
Class II
Quantity
1 kit
Official record key
device-enforcement:Z-2532-2015

Official wording

Reason: Sterility may be compromised

Code information: Lot Numbers: 1505400155

Distribution pattern: US Nationwide Distribution

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Sterility may be compromised