MOOG Curlin Infusion Administration Set, Ref 340-4169, Non-DEHP Microbore Tubing with Non-Vented Bag Spike and distal Ultrasite Needleless Injection Port (Positive Pressure), 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.
Enforcement
- Recall Number
- Z-0702-2018
- Event ID
- 78573
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Zevex Incorporated (dba Moog Medical Medical Devices Group)
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- March 7, 2018
- Initiation Date
- November 10, 2017
- Classification Date
- February 23, 2018
- Termination Date
- December 12, 2018
- Address
- 4314 S Zevex Park Ln, N/A, Salt Lake City, UT, 84123-7881, United States
Description
MOOG Curlin Infusion Administration Set, Ref 340-4169, Non-DEHP Microbore Tubing with Non-Vented Bag Spike and distal Ultrasite Needleless Injection Port (Positive Pressure), 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.
Particulate found on the Curlin spike.
UDI 38148440000594, Lot/serial numbers: CF1520208, CF1522301, and CF1532971.
Distribution was nationwide. There was government and military distribution. Foreign distribution was made to Canada, Saudi Arabia, Turkey, Croatia, United Arab Emirates, and Australia.
785/20-administration set cases