The Recall Desk
HighFDA (Devices)·Z-2108-2014·Announced 2014-07-30

Teleflex Recalls Hudson RCI Breathing Circuits Due to Temperature Probe Defect

Teleflex Medical is recalling Hudson RCI breathing circuits because the temperature probe does not properly connect to the temperature port.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device defect that could compromise the function of a ventilator circuit, representing a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Teleflex Medical is recalling Hudson RCI, Breathing Circuit, Adult Single Limb (W/Connector, Adaptor, Y Piece), Rx Only, Single Patient Use. The product 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 is being conducted because the temperature probe does not properly connect to the temperature port. The affected units are catalog number 1696 with specific lot numbers listed in the agency documentation. A total of 11,679 units were distributed worldwide, including in the United States and in Argentina, Chile, Colombia, and the Philippines.

Healthcare providers and facilities should stop using the affected breathing circuits and contact Teleflex Medical for further instructions on the recall.

The recalled product

Product
Hudson RCI, Breathing Circuit, Adult Single Limb (W/Connector, Adaptor, Y Piece), Rx Only, Single Patient Use. 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 with a Conch
Manufacturer
Teleflex Medical
Category
Medical Device — Ventilator Circuits
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 (12)

  • Catalog Number: 1696
  • Lot numbers: 02K1301986
  • 02L1300010
  • 02L1300037
  • 02L1301081
  • 02L1301783
  • 02M1300190
  • 02M1300236
  • 02A1400518 02A1401286
  • 02A1402358
  • 02B1400178
  • 02B1400715 & 02B1401320.

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

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Same hazard · defective connection

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