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Class I Medical Device Recall: Westmed Inc., BagEasy Manual Resuscitation Devices

Posted Oct 12 2010 9:00pm

Recall Class: Class I

Date Recall Initiated: June 22, 2010

Products: BagEasy Manual Resuscitation Devices

To find all the part and lot numbers and the specific descriptions of the devices affected by this recall, see the Firm Press Release under Useful Links below.

Use: This type of manual emergency resuscitator provides emergency respiratory support using a face mask.

Recalling Firm:
Westmed Inc.
5580 South Nogales Highway, Suite 170
Tucson, Arizona 85706

Reason for Recall: There is a potential for a disconnection at the patient port retention ring assembly. If a disconnection occurs, the device cannot work, which could result in treatment delays while another device is obtained or a different method of resuscitation is used.

Public Contact: Users with questions may contact Westmed Customer Service at 1-800-975-7987, Monday through Friday, between 6 AM to 5 PM, Arizona Standard Time.

FDA District: Los Angeles

FDA Comments:

On June 21, 2010, the company sent a letter to all their customers describing the products, problem and action to be taken by the customer. The recalled devices can be identified by the product labeling that contains the part and lot numbers listed in the firm’s press release.

Users were instructed to STOP distributing the products immediately and to:

  • Notify any facilities that may have received the devices.
  • Contact Customer Service at 1-800-975-7987 to receive a Return Authorization form to return the identified devices.
  • Complete and return the BagEasy Recall Reconciliation Checklist.

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 adverse health consequences or death.

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

Useful Links:

    
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