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U.S. Department of Health and Human Services

Medical Devices

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ConvaTec doing business as Unomedical, Inc., Manual Pulmonary Resuscitator (MPR) (Single-Patient Use)

Recall Class: Class I
Date Recall
Initiated:
October 6, 2009
Product:

Unomedical, Inc. Manual Pulmonary Resuscitator (MPR) -- Single-Patient Use

This recall does not affect MPRs manufactured after March 2008.

These devices were manufactured and distributed from July, 2002 through March, 2008.

Use: A manual pulmonary resuscitator provides emergency respiratory support using a face mask.
Recalling Firm: ConvaTec doing business as Unomedical Inc.
5701-1 South Ware Road
McAllen, Texas 78503-7795
Reason for Recall: A potential malfunction may cause serious injury or death.
Public Contact:

Customers may contact the company at 1-800-634-6003 from 8 AM -5:30 PM, Monday-Thursday (Central Time) and on Fridays from 8 AM-1 PM (Central Time).

For more information, see Useful Links below.

FDA District: New Jersey
FDA Comments:

The company sent a letter to their customers and distributors to arrange for the return and credit of all MPRs that affected by this recall. Through the company’s website, customers will be able to identify the products that are being recalled if the customer has already removed the primary product packaging, and what actions to take.

Class 1 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 injury or death.

Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of these products to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.

Useful Links: