The product is the "FASTx Sternal Intraosseous Device". The expiration date for the recalled products is end of June, 20
FDA device recall Z-2687-2011 · posted 2011-06-28 · Terminated
Recall details
- Recalling firm
- Pyng Medical Corporation
- 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 taken
- 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
- Status
- Terminated
- Product code
- FMI
- Quantity affected
- 402 devices
- Distribution
- Worldwide Distribution--USA (nationwide) and the countries of Australia, Austria, Canada, England, Italy, Mexico, Poland, and Sweden.
- Date initiated
- 2010-11-05
- Date posted
- 2011-06-28
- Date terminated
- 2011-08-10
- Location
- Richmond, Canada
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FASTX STERNAL INTRAOSSEOUS DEVICE (K100124) | Pyng Medical Corp. | 2010-08-31 |