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U.S. Department of Health and Human Services

Class 1 Device Recall

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  Class 1 Device Recall see related information
Date Initiated by Firm October 06, 2009
Date Posted November 04, 2009
Recall Status1 Terminated 3 on August 10, 2010
Recall Number Z-0072-2010
Recall Event ID 53489
510(K)Number K873286  
Product Classification Manual Pulmonary Resuscitator - Product Code BTM
Product Unomedical Infant Manual Pulmonary Resuscitator, Infant Mask & Reservoir Hose. Product ID # 779733
Code Information Product ID # 779733, lot code: 04-39
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 2		 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 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 and Original Applicant = HOSPITAK, INC.
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