Teleflex Incorporated Announces Worldwide Voluntary Recall of Hudson RCI® LIFESAVER® Neonate Manual Resuscitator

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^® LIFESAVER^® Neonate Manual Resuscitator 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 because the intake port may be blocked, which can cause the bag to fail to fill. No patient injury or harm has been reported, however, a delay in treatment may occur while another resuscitator is obtained. A delay in treatment may potentially lead to adverse consequences such as hypoxia.

Teleflex notified both domestic and foreign hospitals and distributors via an Urgent Medical Device recall letter dated May 14, 2015. This recall involves the retrieval of unused product in the field.

At this time, there have been 3 complaints of this issue. There have been no reports of patient injury as a result of this issue. Forty-two (42) lots across five (5) product codes are affected by this recall for a total of 9,333 units distributed to the field.

PRODUCTS AND LOTS AFFECTED:

Product	6 Digit Lot	4 Digit Lot	Product	6 Digit Lot	4 Digit Lot
Code	Number	Number	Code	Number	Number
5361	140514	1420	5362 Cont'd	141115	1446
	140616	1425		141201	1449
	140617	1425		141214	1451
	140621	1425		150112	1503
	140806	1432	5364	140507	1419
	141103	1445		140508	1419
	141117	1447		140514	1420
	141201	1449		140608	1424
	141224	1452		140614	1424
	141227	1452		140623	1426
	150112	1503		140628	1426
5362	140504	1419		140714	1429
	140515	1420		140719	1429
	140517	1420		140806	1432
	140617	1425		140809	1432
	140621	1425	5466	140520	1421
	140812	1433		140923	1439
	140819	1434		140924	1439
	140823	1434	45362	140317	1412
	140929	1440		140630	1427
	141110	1446		141013	1442

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

http://www.teleflex.com/en/recall/Hudson-Lifesaver-Resuscitator-1st-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.