WAYNE, Pa.--(BUSINESS WIRE)--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.
