Z-2714-2014Class I

Hudson RCI Pediatric Anesthesia Breathing Circuits, Single Patient Use, Rx Only

Name: Z-2714-2014 Hudson RCI Pediatric Anesthesia Breathing Circuits, Single Patient Use, Rx Only
Creator: Teleflex Medical
Published: 2014-09-08
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2014-09-08 / Terminated / root cause: design

FDA source

Teleflex Medical began a recall of Hudson RCI Pediatric Anesthesia Breathing Circuits, Single Patient Use, Rx Only, Product Usage: To administer medical gases to a patient during anesthesia. It... on 2014-09-08. FDA classified it as Class I and gives the reason as "The pediatric breathing circuits can crack prior to and during use". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2714-2014
Classification: Class I
Status: Terminated
Initiated: 2014-09-08
Posted: 2014-09-30
Terminated: 2016-08-16
Recalling firm: Teleflex Medical
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.
Product code: CAI Circuit, Breathing (W Connector, Adaptor, Y Piece)
Reason for recall: The pediatric breathing circuits can crack prior to and during use.
Root cause tag: design
FDA root cause: Device Design
Action: Teleflex Medical sent an Urgent Medical Device Recall dated September 8, 2014, to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to immediately discontinue use, quarantine any products with the product codes and lot numbers provided in the notification, return any affected product, complete and return the enclosed Recall Acknowledgement Form and fax it to the attention of Customer Service. For questions contact your local sales representative or Customer Service at 1-866-246-6990.
Quantity in commerce: 27,176 units
Distribution: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2714-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2714-2014	Class I	Terminated	Voluntary: Firm initiated	2014-10-08	2014-09-30

Product code CAI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)