Recall Z-2054-2019— Zevex Incorporated (dba MOOG Medical Devices Group)

Name: FDA recall Z-2054-2019
Creator: U.S. Food and Drug Administration
Published: 2019-02-27

Class II · Terminated

Class II FDA medical device recall by Zevex Incorporated (dba MOOG Medical Devices Group), initiated 2019-02-27, terminated 2021-04-28. It names one FDA 510(k) clearance: K981816. Product: MOOG Curlin Infusion Administration Set, REF 340-4130-V, Non-DEHP Tubing with Non-Vented Bag Spike and Vented 0.2 Micron Filter with add-on check valve, packaged 20 sets/carton, sterile. The firm name on the label is ZEVEX, Inc., Salt Lake City, UT.. Reason: Administration sets leaked at the filter..

Recalling firm: Zevex Incorporated (dba MOOG Medical Devices Group)
Classification: Class II
Status: Terminated
Initiated: 2019-02-27
Terminated: 2021-04-28
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 340-4130-V, Non-DEHP Tubing with Non-Vented Bag Spike and Vented 0.2 Micron Filter with add-on check valve, packaged 20 sets/carton, sterile. The firm name on the label is ZEVEX, Inc., Salt Lake City, UT.

Reason for recall

Administration sets leaked at the filter.

Data sourced from openFDA. This site is unofficial and independent of the FDA.