Stat (TM) Super-Fine (TM) Pen Needles and Allison Medical, Inc. Sure Comfort Pen Needles with Silicone Tip, for human use with insulin pen injector device to administer insulin subcutaneously.
Recall
- Recall Number
- Z-1596-2009
- Event Number
- 52159
- Firm
- Stat Medical Devices, Inc.
- FEI Number
- 1000525253
- Product Code
- FMI
- Status
- Terminated
- Root Cause
- PMA
- Initiated
- May 29, 2009
- Posted
- July 24, 2009
- Terminated
- September 7, 2010
- Address
- 2056 Ne 153rd St, Miami, FL, 33162-6020
Description
Stat (TM) Super-Fine (TM) Pen Needles and Allison Medical, Inc. Sure Comfort Pen Needles with Silicone Tip, for human use with insulin pen injector device to administer insulin subcutaneously.
Stat Pen Needles with silicone coating have not been cleared by FDA for use with silicone coating which could significantly affect the safety and effectiveness of the device.
An "Urgent: Medical Device Recall Notification" letter dated June 18, 2009 was issued to direct customers requesting return of affected product and requesting they send notification to any customers which may have received the affected product from them. Direct questions about the recall to Stat Medical Devices by calling 1-978-774-1469.
Worldwide Distribution -- US (CO and Puerto Rico), Canada, and Saudi Arabia.
6,424,100 total pen needles