Recall Z-2053-2019— Zevex Incorporated (dba MOOG Medical Devices Group)

Name: FDA recall Z-2053-2019
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, Non-DEHP Tubing with Non-Vented Bag Spike and Vented 0.2 Micron Filter, packaged 20 sets/carton, 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: 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, Non-DEHP Tubing with Non-Vented Bag Spike and Vented 0.2 Micron Filter, packaged 20 sets/carton, 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

Administration sets leaked at the filter.

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