Z-2525-2015 Class II Terminated
FDA device recall Z-2525-2015 was initiated by Covidien LLC on Aug 6, 2015 and is designated Class II. Reason for recall: Sterility may be compromised The recall status is terminated (terminated Jun 29, 2017). Affected quantity: 207,876.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 9, 2015
- Initiation Date
- Aug 6, 2015
- Termination Date
- Jun 29, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 207,876
Product Description
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.
Reason for Recall
Sterility may be compromised
Distribution Pattern
US Nationwide Distribution
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2525-2015
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026