Recall Z-0700-2018— Zevex Incorporated (dba Moog Medical Medical Devices Group)
Class II · Terminated
Class II FDA medical device recall by Zevex Incorporated (dba Moog Medical Medical Devices Group), initiated 2017-11-10, terminated 2018-12-12. It names one FDA 510(k) clearance: K981816. Product: MOOG Curlin Infusion Administration Set, Ref 340-4166, Non-DEHP Microbore Tubing with Non-Vented Spike, 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.. Reason: Particulate found on the Curlin spike..
- Recalling firm
- Zevex Incorporated (dba Moog Medical Medical Devices Group)
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-11-10
- Terminated
- 2018-12-12
- Firm location
- Salt Lake City, UT, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
MOOG Curlin Infusion Administration Set, Ref 340-4166, Non-DEHP Microbore Tubing with Non-Vented Spike, 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.
Reason for recall
Particulate found on the Curlin spike.
Data sourced from openFDA. This site is unofficial and independent of the FDA.