Device product
MOOG Curlin Infusion Administration Set, Ref 340-4134, Non-DEHP Microbore Tubing with Non-Vented Bag Spike and Y-Site with Check Valve, 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-0699-2018
Product summary
- Event
- Event 78573
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,497/20-administration set cases
- Official record key
device-enforcement:Z-0699-2018
Official wording
Reason: Particulate found on the Curlin spike.
Code information: UDI 38148440000495, Lot/serial numbers: CF1518304, CF1521104, CF1524301, CF1523803, CF1528603, and CF1613101.
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