Class 1 Device Recall Evergreen, Hospitak and McKesson.

• Date Initiated by Firm: October 06, 2009
• Date Posted: November 04, 2009
• Recall Status: Terminated on August 10, 2010
• Recall Number: Z-0048-2010
• Recall Event ID: 53489
• 510(K)Number: K873286
• Product Classification: Manual Pulmonary Resuscitator - Product Code BTM
• Product: Infant Manual Pulmonary Resuscitator with reservoir tube, face mask & Gas sampling elbow. Product ID # 12-8714; 731-E, 731MM; 86-731E. Packaged under the name of Evergreen, Hospitak and McKesson.
• Code Information: Product ID # 12-8714; lot numbers: 04-04 04-10 04-13 04-35 04-42 04-47 04-51 05-07 05-17 05-28 05-32 05-48 07-13 07-17; Product ID# 731-E: lot numbers: 03-24 03-42 03-43 04-06 04-09 04-18 04-31 04-33 04-38 04-39 04-45 04-49 05-08 05-12 05-17 05-21 05-28 05-42 07-14 07-29 07-51: Russia: 03-17 Mexico: 04-06 04-09 04-19 04-31 04-38 04-42 05-05 05-08 05-26 05-28 05-42 05-46 05-48 06-04 06-13 06-26 06-39 07-09 07-51 Japan: 03-20 03-34 04-05 04-06 04-19 04-49 04-50 05-08 06-13 06-26: Product ID # 731MM; Japan, Lot code 07-14; Mexico, lot code: 04-20 Product ID # 86-731E; lot numbers: 06-18 06-39 06-43 07-11 07-17 07-43 07-47 07-51; Product ID # 731MM, lot codes: Russia: 04-07; Vietnam: 04-07 04-07 04-07 04-07 04-07
• Recalling Firm/ Manufacturer: Unomedical; 5701 S Ware Rd; Mcallen TX 78503-7795
• For Additional Information Contact: Raymond Mendoza; 800-634-6003
• Manufacturer 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.
• FDA Determined Cause: Device Design
• Action: 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.
• Quantity in Commerce: over 200 total lots
• Distribution: Worldwide distribution: USA, Argentina, Canada, Denmark, France, Greece, India, Italy, Japan, Mexico, Paraguay, Peru, Poland, Russia and Vietnam.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = BTM