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
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
Sterility may be compromised