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Recall Observatory FDA recall evidence

Device product

Monoject 0.9% Saline Flush Prefill Double Pouch Item Code: 8881570129 Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular access devices.

Z-2525-2015

August 06, 2015

Class II

Product summary

Firm
Covidien LLC
Event
Event 71893
Status
Terminated
Classification
Class II
Quantity
207,876
Official record key
device-enforcement:Z-2525-2015

Official wording

Reason: Sterility may be compromised

Code information: Lot Numbers: P15035 P15036 P15037 P15041 P15042 P15046 P15047 P15048 P15049 P15056 P15057 P15058 P15059 P15063 P15064 P15069 P15070 P15071 P15078 P15079 P15080 P15081 P15091

Distribution pattern: US Nationwide Distribution

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Sterility may be compromised