Westmed, Inc. of Tucson, Arizona, has issued a nationwide recall of its<"http://www.yourlawyer.com/practice_areas/defective_medical_devices"> BagEasy Manual Resuscitation Devices, the US Food and Drug Administration (FDA) just announced. The recall was issued for 24,384 units.
The select lots of the BagEasy Manual Resuscitation Devices have been found to have a potential for disconnection at the retention ring of the patient port manifold. This disconnection issue will render the unit inoperable, which could result in treatment delays while another unit is obtained or a technician switches to a different method of resuscitation. Because of the seriousness of this defect, the recall is classified by the FDA as a Class I.
The FDA describes a Class I recall 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.â€¨
Consumers who have units from the identified lots of the recalled BagEasy Manual Resuscitation Devices should stop using the product and return it to Westmed or their distributor. A complete list of part numbers and lot numbers can be accessed at: http://www.fda.gov/Safety/Recalls/ucm225844.htm
Westmed become aware of the potential for disconnection at the patient port retention ring assembly of the BagEasy device after it received reports from three separate facilities regarding units disconnecting during setup or use. In the reported cases, healthcare providers obtained another unit and continued with setup or treatment.
The BagEasy Manual Resuscitation Device was distributed to other medical device distribution companies and directly to hospitals and other treatment facilities. The recalled device can be identified by product labeling that contains part and lot numbers identified at http://www.fda.gov/Safety/Recalls/ucm225844.htm
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. Westmed can be reached, toll-free, at 1-800-975-7987, Monday through Friday from 6:00 a.m. to 5:00 p.m., 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:
â€¢ Online: www.fda.gov/medwatch/report.htm
â€¢ Regular Mail: Use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm and mail to MedWatch 5600 Fishers Lane, Rockville, Maryland, 20852-9787
â€¢ Fax: 1-800-FDA-0178