Zevex Incorporated (dba Moog Medical Medical Devices Group): MOOG Curlin Infusion Administration Set, Ref 340-4168, Non-DEHP Microbore Tubing with Non-Vented Bag Spike and distal Female Luer Y-Site wi

Is my product affected?

MOOG Curlin Infusion Administration Set, Ref 340-4168, Non-DEHP Microbore Tubing with Non-Vented Bag Spike and distal Female Luer Y-Site with Check Valve, Anti-Siphon Valve included for Free Flow Protection, packaged 20/box, for use with the Moog Curlin Ambulatory Volumetric Infusion Pump, RX, Steri

• UPC 38148440000587

Check against the official notice below — it lists the full affected range.

What happened

Zevex Incorporated has recalled MOOG Curlin Infusion Administration Sets due to particulate found on the Curlin spike. The affected product is a non-DEHP microbore tubing set with a non-vented bag spike and distal female Luer Y-site (Ref 340-4168, UDI 38148440000587). The recall involves 2,417 cases across 11 lot/serial numbers that were distributed nationwide to government, military, and commercial customers, as well as internationally to Canada, Saudi Arabia, Turkey, Croatia, United Arab Emirates, and Australia.

The recall record does not specify a remedy or recommended action for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Particulate found on the Curlin spike.

Details from the source

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. Quantity: 2,417/20-administration set cases Lot/code info: UDI 38148440000587, Lot/serial numbers: CF1517404, CF1519506, CF1521211, CF1519506, CF1522501, CF1526503, CF1530704, CF1530704, CF1530704, CF1611001, and CF1618152.

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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