Device product
Mahurkar Elite Acute Dual Lumen Catheter Tray, Curved Extensions with IC* Safety Components, 12 Fr x 16 cm Item Code: 8888222416 Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular access devices.
Z-2531-2015
Product summary
- Firm
- Covidien LLC
- Event
- Event 71893
- Status
- Terminated
- Classification
- Class II
- Quantity
- 67 kits
- Official record key
device-enforcement:Z-2531-2015
Official wording
Reason: Sterility may be compromised
Code information: Lot Numbers: 1506200119 1511100102
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Sterility assurance
Sterility may be compromised