The Recall Desk
HighFDA (Devices)·Z-2689-2014·Announced 2014-10-01

CareFusion AirLife Heated Infant Breathing Circuit Recalled for Material Change

CareFusion is recalling approximately 318,280 heated infant breathing circuits due to a regulatory compliance risk involving a material change to the gas pathway.

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 is classified as FDA Class II and involves a potential safety impact on a medical device used for infant ventilation. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High (3).

Plain-English summary

CareFusion 2200 Inc is recalling approximately 318,280 units of the CareFusion AirLife Heated Infant Breathing Circuit. These devices are used with ventilators to administer mechanical ventilation to patients. The recall covers various product codes and lot configurations, including infant and neonatal circuits.

The recall was initiated due to a regulatory compliance risk involving a material change. According to the source text, changes to the gas pathway may potentially impact the safety of the device and the quality of the gas condensates delivered to the patient. The agency classification for this recall is Class II.

The affected devices were distributed worldwide, including nationwide in the United States and in specific countries such as Canada, China, Kuwait, Mexico, Saudi Arabia, and Switzerland. Consumers and healthcare facilities should check their inventory against the specific product codes listed in the official recall notice and contact CareFusion for further instructions on handling the devices.

The recalled product

Product
CareFusion AirLife Heated Infant Breathing Circuit Product Usage: Respiratory breathing circuits are used with a ventilator when mechanical ventilation is administered to a patient.
Manufacturer
Carefusion 2200 Inc
Category
Medical Device — Respiratory
Hazard
Affected units
318,280

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 (20)

  • All lots of the following products: 1) CIRCUIT RESP INFANT 4FT HTD 30/CS
  • Product Code 10127-4H1
  • 2) CIRCUIT RESP INFANT 4FT 30/CS
  • Product Code 10331N-4S2
  • 3) CIRCUIT RESP INFANT 4FT HTD 30/CS
  • Product Code 10351-4H2
  • 4) CIRCUIT RESP INFANT 4FT HTD 30/CS
  • Product Code 10387-4S2
  • 5) CIRCUIT RESP INFANT PV HTD 5FT 30/CS
  • Product Code 10392-503
  • 6) CIRCUIT RESP INFANT 5FT HTD 30/CS
  • Product Code 10485-4H2
  • 7) CIRCUIT INFANT INSP LINE HTD 8FT 30/CS
  • Product Code 10520-504
  • 8) CIRCUIT RESP INFANT 4FT HTD 30/CS
  • Product Code 10555-4S2
  • 9) CIRCUIT INFANT INSP LINE HTD 5FT 30/CS
  • Product Code 10680-504
  • 10) CIRCUIT RESP INFANT 4FT HTD 30/CS
  • Product Code 10706-4S2

Distribution

Distributed nationwide across the United States.

The notice also names 18 states specifically:

Related recalls

Same manufacturer · Carefusion 2200 Inc

See all →