Agency classClass IOur severity:Severe FDA (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.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "The pediatric breathing circuits can crack prior to and during use."

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
Category: Medical Device — Anesthesia Equipment
Hazard: cracking
device-failure
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:

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