Teleflex Incorporated Announces Worldwide Voluntary Recall of Hudson RCI® Pediatric Anesthesia Breathing Circuits

WAYNE, Pa.--()--Teleflex Incorporated announced today that the U.S. Food and Drug Administration (FDA) has classified the voluntary medical device recall of Hudson RCI® Pediatric Anesthesia Breathing Circuits as a Class 1 recall. FDA defines Class I recalls as, “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.”

Teleflex is recalling the products referenced above due to receipt of complaints that the ends of the pediatric breathing circuits can crack prior to and during use. If the circuits crack during use, there will be a need for immediate replacement of the device, and possible respiratory distress to the patient.

Teleflex notified both domestic and foreign hospitals and distributors via an Urgent Medical Device recall letter dated September 10, 2014. This recall involves the retrieval of unused product in the field.

At this time, there have been 24 complaints of this issue. There have been no reports of patient injury as a result of this issue. Six (6) product codes over thirty (30) lots are affected by this recall for a total of 27,176 units distributed to the field.

PRODUCTS AND LOTS AFFECTED:

Product Code     Lot Number     Product Code     Lot Number     Product Code     Lot Number
313901     02F1300085     353801     02E1300623     353901     02F1300101
353900     02D1300854     353801     02F1300098     353801     02E1301891
353901     02E1300618     353801     02H1300172     353901     02G1300879
353911     02G1300296     353801     02H1300454     353911     02F1300177
353911     02G1300861     353801     02H1301128     353801     02J1300876
353911     02F1300729     353801     02F1300180     353801     02H1301838
313901     02G1300088     353901     02E1301378     353811     02E1301383
353811     02E1300090     353900     02E1301892     353801     02J1302412
353911     02F1300102     353900     02F1300100     353811     02E1301867
353900     02F1302029     353901     02F1302047     353801     02B1400324

The original recall notice can be found at Teleflex’s website:

http://www.teleflex.com/en/investor/documents/pediatric-tubing-first-customer-notification.pdf

Consumers with questions may contact the company at 1-866-246-6990; 8am to 8pm, ET, Monday through Friday.

Any adverse reactions experienced with the use of this product, and/or quality problems can also be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch -

ABOUT TELEFLEX INCORPORATED

Teleflex is a leading global provider of specialty medical devices for a range of procedures in critical care and surgery. Our mission is to provide solutions that enable healthcare providers to improve outcomes and enhance patient and provider safety. Headquartered in Wayne, PA, Teleflex employs approximately 11,500 people worldwide and serves healthcare providers in more than 150 countries. For additional information about Teleflex please refer to www.teleflex.com.

Contacts

Teleflex Incorporated
Jake Elguicze
Treasurer and Vice President of Investor Relations
610-948-2836

Release Summary

Teleflex Incorporated Announces Worldwide Voluntary Recall of Hudson RCI Pediatric Anesthesia Breathing Circuits

Contacts

Teleflex Incorporated
Jake Elguicze
Treasurer and Vice President of Investor Relations
610-948-2836