FDA recall Z-0698-2018

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 for recall

Particulate found on the Curlin spike.

Distribution

Distribution was nationwide. There was government and military distribution. Foreign distribution was made to Canada, Saudi Arabia, Turkey, Croatia, United Arab Emirates, and Australia.

Key facts

Status

Terminated

Initiation date

2017-11-10

Report date

2018-03-07

Termination date

2018-12-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Salt Lake City, UT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0698-2018