Product Description
Adult Manual Pulmonary Resuscitator with reservoir tube, face mask & Gas Sampling elbow. Product ID # 5807; 12-8703, 723-E (Foreign Distribution only), 723MM.
Packaged under the name of Dynarex and Evergreen.
Reason for Recall
In some Manual Pulmonary Resuscitator units the duckbill valve and retention ring inside the patient valve housing may become dislodged and fall into the MPR bag/body. If this occurs, the MPR may lose its ability to generate the positive pressure necessary necessary to ventilate the patient.
Action Details
Unomedical issued Press on October 6, 2009. Letters were sent to customers on October 7, 2009 via UPS - return receipt. Letters explained the reason for recall and the potential hazard to patients. The letter contains a list of all affected lot numbers as well as a picture which shows that units with a clearly visible blue ring are NOT affected. Distributors are asked to examine inventory and quarantine all affected product and return the response form, even if no recalled product is in inventory. If the product was further distributed, the letter requests that a copy of the letter be sent to all customers and for returns, follow Distributor actions listed in the letter. Retailers and end users/Hospitals/EMT's are asked to perform a count of recalled product, segregate it and return the response form. All customers are asked to call 1-800-634-6003 where they will be assigned a RGA number and given instructions on how to return product.
Contact information: 8:00AM - 5:30 PM Central Time Monday through Thursday and 8:00AM to 1:00 PM on Fridays, Central Time.
Distribution Pattern
Worldwide distribution: USA, Argentina, Canada, Denmark, France, Greece, India, Italy, Japan, Mexico, Paraguay, Peru, Poland, Russia and Vietnam.
Code Information / Serial Numbers
Product ID # 5807; Lot numbers 07-39, 0749; Product ID# 12-8703; lot numbers: 04-28 05-07 05-20 05-43 07-08: Product No. 723-E (Foreign Distribution only) Greece: 04-09; Japan: 04-22; Peru: 02-36; Product ID # 723MM; lot code: Vietnam: 03-45 04-06 04-38 05-10 05-11 05-29 05-42 05-49 06-30 06-40 06-41 07-02 07-07 07-09 07-16 07-17 07-38 07-47
Public Record Disclaimer
This page represents an index of public-record FDA device recalls. It does not imply current safety or compliance status of the product. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Refer to official government sources for primary safety alerts.