Medical Devices

Teleflex Hudson RCI Lifesaver Single Patient Use Manual Resuscitator Intake Port Blockage

Recall Class: Class I

Date Recall Initiated: May 15, 2015

Device: Lifesaver Single Patient Use Manual Resuscitator

Use:
The Hudson RCI Lifesaver Single Patient Use manual resuscitator with pressure monitoring port is a disposable medical device used to provide temporary breathing support for patients during periods of acute ventilatory failure. The primary users of this device are hospitals and clinics and the patient population includes infants and children.

Recalling Firm:
Teleflex Medical
2917 Weck Drive
Research Triangle Park, North Carolina 27709-0186

Reason for Recall:
The oxygen intake port may be blocked which can prevent the bag from filling. This may prevent the device from delivering breathing support to the patient. A delay in treatment may potentially lead to patient injury or death. To date, Teleflex has not received any reports of patient injury or death related to this recall.

Public Contact: For questions about this recall, contact Teleflex Customer Service at cs@teleflex.com or 1-866-246-6990, Monday - Friday, 8:00 a.m. - 7:00 p.m., Eastern Time, or call your local sales representative.

FDA District: Atlanta District Office

More Information about this Recall:
On May 14, 2015, Teleflex sent an urgent medical device recall letter to customers asking them to immediately discontinue use and quarantine the recalled product. Customers are asked to return any affected product together with a completed Recall Acknowledgement Form, for consolidation and return to Teleflex Medical. The letter also requested a sub-recall of the product through the distributers instructing them to immediately discontinue distribution and quarantine the recalled products, and notify their customers who have received the product of the recall.

About Class I Recalls
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.
 

Page Last Updated: 07/02/2015
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