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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 2 Recall
FASTx Sternal Intraosseous Device		see related information
Date Posted June 28, 2011
Recall Number Z-2687-2011
Product The product is the "FASTx Sternal Intraosseous Device". The expiration date for the recalled products is end of June, 2012. The device is used to insert an infusion tube into the manubrium (upper portion of the sternum) of a patient. It is intended for intraosseous infusion as an alternative to intravenous access, to facilitate emergency resuscitation through the use of drugs and fluids. It is indicated for use in establishing a sternal intraosseous access route in adult and adolescent patients (12 years of age and older) requiring vascular administration of drugs or fluids to facilitate emergency resuscitation.
Code Information 3 lot numbers: "20100609", "20100610", and 20100611". Format is "YYYYMMXX" where YYYY is the year of manufacture, MM is the month, and XX is a sequential number identifying different lots manufactured in the same month.
Recalling Firm/
Manufacturer		 Pyng Medical Corporation
13511 Crestwood Pl Rm 7
Richmond
For Additional Information Contact Michele Tyler
604-303-7964 Ext. 212
Reason for
Recall		 Device failed to operate; the insertion of the infusion tube of the FASTx Sternal Intraosseous Device was not achieved in live subjects.
Action Pyng Medical Corp. sent a "FSN/RECALL FOR FASTx STERNAL INTRAOSSEOUS DEVICE, P/N FASTx -H" letter dated November 5, 2010 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. Customers are to cease distribution and use of all devices. All devices remaining in inventory should be quarantined. Customers are asked to complete the information at the bottom of the letter and return the product by FEDEx. Questions regarding this notice should contact the Director of Operations at 1-604-303-7964 ext. 211.
Quantity in Commerce 402 devices
Distribution Worldwide Distribution--USA (nationwide) and the countries of Australia, Austria, Canada, England, Italy, Mexico, Poland, and Sweden.
 
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