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.
FDA Recall Z-2687-2011 · Posted 2011-06-28
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Recalling FirmPyng Medical Corporation
Recall StatusTerminated
Product CodeFMI
Date Initiated2010-11-05
Date Terminated2011-08-10
Product Quantity402 devices
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.
Firm 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.
Root Cause
Other
Distribution Pattern
Worldwide Distribution--USA (nationwide) and the countries of Australia, Austria, Canada, England, Italy, Mexico, Poland, and Sweden.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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