Z-2687-2011

The product is the "FASTx Sternal Intraosseous Device". The expiration date for the recalled products is end...

Name: Z-2687-2011 The product is the "FASTx Sternal Intraosseous Device". The expiration date for the recalled products is end...
Creator: Pyng Medical Corporation
Published: 2010-11-05
License: https://open.fda.gov/license/

Pyng Medical Corp. / initiated 2010-11-05 / Terminated

FDA source

Pyng Medical Corporation began a recall of 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... on 2010-11-05. The reason FDA records is "Device failed to operate; the insertion of the infusion tube of the FASTx Sternal Intraosseous Device was not achieved in live subjects". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2687-2011
Status: Terminated
Initiated: 2010-11-05
Posted: 2011-06-28
Terminated: 2011-08-10
Recalling firm: Pyng Medical Corp.
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.
Product code: FMI Needle, Hypodermic, Single Lumen
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 root cause: Other
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.
Product codes and lots: 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.

Product code FMI

K100124Class IIFastx Sternal Intraosseous DevicePyng Medical Corp. / cleared 2010-08-31

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)