The Recall Desk
ModerateFDA (Devices)·Z-2107-2014·Announced 2014-07-30

Teleflex Recalls Hudson RCI Breathing Circuits Due to Temperature Probe Defect

Teleflex Medical is recalling 11,679 Hudson RCI Breathing Circuits because the temperature probe does not properly connect to the temperature port.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity score.

Plain-English summary

Teleflex Medical is recalling 11,679 units of the Hudson RCI, Breathing Circuit, Adult, Single Limb w/Heated Wire. This medical device is intended as a conduit for respiratory gas between a patient and a ventilator and includes heated wires for use with a Concha Column Humidifier.

The recall was initiated because the temperature probe does not properly connect to the temperature port. The affected products are identified by Catalog Number 780-96 and Lot numbers 02L1300073 and 02A140133.

The devices were distributed worldwide, including in the United States (CA, FL, KS, KY, MA, MI, MO, NC, NE, NJ, NY, OH, PA, TN, TX, and VA) and in Argentina, Chile, Colombia, and the Philippines. Healthcare facilities and users should stop using the affected devices and contact Teleflex Medical for further instructions.

The recalled product

Product
Hudson RCI, Breathing Circuit, Adult, Single Limb w/Heated Wire, [Respiratory Gas Humidifier, (Direct Patient Interface)]. The Hudson Heated Wire Ventilator Circuit is intended as a conduit for respiratory gas between a patient and a ventilator, and includes heated wires for use
Manufacturer
Teleflex Medical
Category
Medical Device — Respiratory Equipment
Hazard
Affected units
11,679

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Catalog Number: 780-96
  • Lot numbers: 02L1300073 & 02A140133.

Distribution

Distributed in 16 states:

Part of a larger recall action

This product is one of 2 recalled by Teleflex Medical under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Teleflex Medical

See all →

Same hazard · malfunction

See all →