Recall Z-2687-2011 ยท FMI Needle, Hypodermic, Single Lumen
Pyng Medical Corporation
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 in
| Date | Jun 28, 2011 (initiated Nov 5, 2010) |
| Status | Terminated |
| Reason | Device failed to operate; the insertion of the infusion tube of the FASTx Sternal Intraosseous Device was not achieved in live subjects. |
| 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 | 402 devices |
| Distribution | Worldwide Distribution--USA (nationwide) and the countries of Australia, Austria, Canada, England, Italy, Mexico, Poland, and Sweden. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K100124 | FASTX STERNAL INTRAOSSEOUS DEVICE Pyng Medical Corp., Aug 31, 2010 |