Recall Z-0698-2018— Zevex Incorporated (dba Moog Medical Medical Devices Group)

Name: FDA recall Z-0698-2018
Creator: U.S. Food and Drug Administration
Published: 2017-11-10

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 340-4133, Non-DEHP Microbore Tubing with Non-Vented Bag Spike and Needleless Injection Port (Positive Pressure), 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 record

K981816 — CUE AMBULATORY VOLUMETRIC INFUSION PUMPBecton Dickinson Curlin, LLC·cleared 1998-12-04

K-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 340-4133, Non-DEHP Microbore Tubing with Non-Vented Bag Spike and Needleless Injection Port (Positive Pressure), 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.