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U.S. Department of Health and Human Services

Class 2 Device Recall FASTx Sternal Intraosseous Device

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 Class 2 Recall
FASTx Sternal Intraosseous Device
see related information
Date Posted June 28, 2011
Recall Status1 Terminated on August 10, 2011
Recall Number Z-2687-2011
Recall Event ID 59019
Premarket Notification
510(K) Number
K100124 
Product Classification Needle, Hypodermic, Single Lumen - Product Code FMI
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
Manufacturer 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.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Pending
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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FMI and Original Applicant = PYNG MEDICAL CORP.
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