Device product
MAHURKAR 12Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20cm, Straight Extensions, PASS Tray Item Code: 8888104003HP Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular access devices.
Z-2537-2015
Product summary
- Firm
- Covidien LLC
- Event
- Event 71893
- Status
- Terminated
- Classification
- Class II
- Quantity
- 550 kits
- Official record key
device-enforcement:Z-2537-2015
Official wording
Reason: Sterility may be compromised
Code information: Lot Numbers: 1504700147, 1507600096
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Sterility assurance
Sterility may be compromised