Westmed, Inc. Issues Nationwide Recall of BagEasy Manual Resuscitation Devices
Posted Sep 15 2010 12:46pm
FOR IMMEDIATE RELEASE -- September 14, 2010 - Westmed, Inc., Tucson, AZ, is initiating a nationwide recall of 24,384 units of BagEasy Manual Resuscitation Devices. The select lots listed below of the BagEasy device have been found to have a potential for disconnection at the retention ring of the patient port manifold. Disconnection causes the unit to be inoperable, which potentially could result in treatment delays while another unit is obtained or technician switches to a different method of resuscitation. This recall is classified by the FDA as a Class I Recall.
Consumers who have units from the identified lots of BagEasy manual resuscitation devices which are being recalled should stop using and return the product to Westmed or their distributor.
The recall includes the following part numbers and lot numbers:
BagEasy, Adult Resuscitator, W/Mask
BagEasy, Adult Resuscitator, W/Peep and Mask
Child BagEasy Resuscitator w/Large and Regular Mask
Adult BagEasy Resuscitator w/Mask and CO2 EasyTM
BagEasy, Child Resuscitator, W/Peep and Mask
BagEasy, Child Resuscitator, W/Peep
BagEasy, Child Resuscitator, W/Mask
BagEasy, Infant Resuscitator, W/Peep and Mask
BagEasy, Infant Resuscitator, W/Mask
BagEasy, Neonatal/Infant Resuscitor, W/Mask
BagEasy, Neonatal/Infant Resuscitator, W/Peep and Mask
Manual Resuscitator Adult, PSS
Manual Resuscitator Pediatric, PSS
The firm voluntarily recalled the products after learning of units disconnecting at user facilities. FDA has been apprised of this action.
Westmed has become aware of a potential for disconnection at the patient port retention ring assembly of the BagEasy manual resuscitation device after receiving reports from three separate facilities regarding units disconnecting during setup or use. The healthcare providers obtained another unit and continued with setup or treatment.
The BagEasy manual resuscitation device was distributed to other medical device distribution companies as well as directly to hospitals and other treatment facilities. It can be identified by product labeling that contains part and lot numbers identified above.
Westmed is notifying its distributors and customers by certified mail and direct contact by sales representatives and is arranging for return of all recalled products.
Consumers with questions may contact the company at 1-800-975-7987 Monday through Friday 6 AM to 5 PM Arizona Standard Time.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm.
Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787