Device product
MOOG Curlin Infusion Administration Set, Ref 340-4168, Non-DEHP Microbore Tubing with Non-Vented Bag Spike and distal Female Luer Y-Site with Check Valve, Anti-Siphon Valve included for Free Flow Protection, packaged 20/box, for use with the Moog Curlin Ambulatory Volumetric Infusion Pump, RX, Sterile. Product Usage: Administration set to be used with the Moog Curlin infusion Pump. The pump can be used for intravenous, intra-arterial, epidural, subcutaneous, or enteral infusions.
Z-0701-2018
Product summary
- Event
- Event 78573
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,417/20-administration set cases
- Official record key
device-enforcement:Z-0701-2018
Official wording
Reason: Particulate found on the Curlin spike.
Code information: UDI 38148440000587, Lot/serial numbers: CF1517404, CF1519506, CF1521211, CF1519506, CF1522501, CF1526503, CF1530704, CF1530704, CF1530704, CF1611001, and CF1618152.
Distribution pattern: Distribution was nationwide. There was government and military distribution. Foreign distribution was made to Canada, Saudi Arabia, Turkey, Croatia, United Arab Emirates, and Australia.
Derived failure modes
-
Foreign material or chemical contamination
Particulate