The Recall Desk
HighFDA (Devices)·Z-2714-2014·Announced 2014-10-08

Teleflex Recalls Hudson Pediatric Anesthesia Breathing Circuits Due to Cracking

Teleflex Medical is recalling Hudson RCI Pediatric Anesthesia Breathing Circuits because they can crack prior to and during use.

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 with a defect (cracking) that poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Teleflex Medical is recalling Hudson RCI Pediatric Anesthesia Breathing Circuits, which are single-patient use devices intended to administer medical gases to patients during anesthesia. The recall involves 27,176 units of the product.

The recall was initiated because the pediatric breathing circuits can crack prior to and during use. The affected products were distributed worldwide, including nationwide in the United States and in specific countries such as Belgium, Canada, Chile, China, Colombia, Korea, Mexico, Peru, Venezuela, and Zaire.

Healthcare providers and patients should stop using the affected breathing circuits and contact Teleflex Medical for further instructions. The specific product codes and lot numbers are listed in the official recall documentation.

The recalled product

Product
Hudson RCI¿ Pediatric Anesthesia Breathing Circuits, Single Patient Use, Rx Only, Product Usage: To administer medical gases to a patient during anesthesia. It provides both an inhalation and exhalation route and may include a connector, adaptor, and Ypiece.
Manufacturer
Teleflex Medical
Affected units
27,176

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)

  • Product Code: 313905
  • Lot #02F1300085
  • Product Code: 353900
  • Lot #02D1300584
  • Product Code: 353901
  • Lot #0241300618
  • Product Code: 353911
  • Lot #02G1300296
  • 02G1300861
  • 02F1300729
  • Product Code: 313901
  • Lot #02G1300088
  • Product Code: 353811
  • Lot #02E1300090
  • 02E1301383 & 02E1301867
  • Lot #02F1300102 & 02F1300177
  • Lot #02F1302029
  • Product Code: 353801
  • Lot #02E1300623
  • 02FF1300098

Distribution

Distributed nationwide across the United States.

The notice also names 14 states specifically: