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FDA (Device enforcement)Recalled 2017-11-10closedclass ii

Zevex Incorporated (dba Moog Medical Medical Devices Group): MOOG Curlin Infusion Administration Set, Ref 340-4166, Non-DEHP Microbore Tubing with Non-Vented Spike, Anti-Siphon Valve included for Free

Is my product affected?

MOOG Curlin Infusion Administration Set, Ref 340-4166, Non-DEHP Microbore Tubing with Non-Vented Spike, Anti-Siphon Valve included for Free Flow Protection, packaged 20/box, for use with the Moog Curlin Ambulatory Volumetric Infusion Pump, RX, Sterile. Product Usage: Administration set to be used wi

  • UPC 38148440000563

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

What happened

Zevex Incorporated has recalled its MOOG Curlin Infusion Administration Set (Ref 340-4166), a non-DEHP microbore tubing product with non-vented spike and anti-siphon valve, due to particulate found on the Curlin spike. The recall affects approximately 7,979 cases distributed nationwide, including to government and military facilities, as well as internationally to Canada, Saudi Arabia, Turkey, Croatia, United Arab Emirates, and Australia. The affected products are identified by UDI 38148440000563 and specific lot/serial numbers including CF1515305, CF1519505, CF1523004, CF1524405, CF1529201, CF1528602, CF1532105, CF1601204, CF1604701, CF1605403, CF1609005, CF1609604, and CF1614732.

The recall record does not specify a remedy or recommend any 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: 7,979/20-administration set cases Lot/code info: UDI 38148440000563, Lot/serial numbers: CF1515305, CF1519505, CF1523004, CF1524405, CF1529201, CF1528602, CF1532105, CF1601204, CF1604701, CF1605403, CF1609005, CF1609604, and CF1614732.

Source

Official record: FDA (Device enforcement) ↗

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

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