CLASS I Device recall · Reported 8 Oct 2014 · FDA Enforcement Report

Hudson RCI¿ Pediatric Anesthesia Breathing Circuits recalled

Teleflex Medical is recalling Hudson RCI¿ Pediatric Anesthesia Breathing Circuits, Single Patient Use, distributed nationwide in the US. The recall was initiated on 8 Sep 2014 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesProduct 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; Product Code: 353911, Lot #02F1300102 & 02F1300177; Product Code: 353900, Lot #02F1302029; Product Code: 353801, Lot #02E1300623, 02FF1300098, 02H1300172, 02H1300454, 02H1301128, 02F300180, 02E1301891, 02J1300876, 02H1301838, 02J1302412 & 02B1400324; Product Code: 353901, Lot #02E1301378; Product Code: 353900, Lot #02E1301892, 02F1300100 and Product Code: 353901, Lot #02F1302047, 02F1300101 & 2G1300879.

Quantity recalled27,176 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2714-2014
FDA event ID: 69194
Recalling firm: Teleflex Medical, Durham, NC
Classification: Class I
Status: Terminated
Recall initiated: 8 Sep 2014
FDA classified: 30 Sep 2014
Reported: 8 Oct 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

8 Sep 2014	Recall initiated by company
30 Sep 2014	Classified by FDA	+22 days
8 Oct 2014	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The pediatric breathing circuits can crack prior to and during use.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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.

Where it was distributed

Worldwide Distribution - US Nationwide in the states of AZ, CA, FL, IL, KY, OH, NJ, NY, TX, LA, OR, SD, WA, including Puerto Rico, and the countries of Belgium, Canada, Chile, China, Colombia, Korea, Mexico, Peru, Venezuela and Zaire.

Nationwide Arizona California Florida Illinois Kentucky Louisiana New Jersey New York Ohio Oregon Puerto Rico South Dakota Texas Washington

Questions about this recall

Why was it recalled?

The pediatric breathing circuits can crack prior to and during use.

Which lots are affected?

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; Product Code: 353911, Lot #02F1300102 & 02F1300177; Product Code: 353900, Lot #02F1302029; Product Code: 353801, Lot #02E1300623, 02FF1300098, 02H1300172, 02H1300454, 02H1301128, 02F300180, 02E1301891, 02J1300876, 02H1301838, 02J1302412 & 02B1400324; Product Code: 353901, Lot #02E1301378; Product Code: 353900, Lot #02E1301892, 02F1300100 and Product Code: 353901, Lot #02F1302047, 02F1300101 & 2G1300879.

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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