| Date Posted |
July 24, 2009 |
| Recall Number |
Z-1596-2009 |
| Product |
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. |
| Code Information |
Part # Lot # Exp Date
PNS-100 SBSM-1107-1 11/2012
SBSM-0608-1 06/2013 and
SBSM-1008-1 10/2013;
PNX-100 SBSM-1107-1 11/2012
SBSM-0408-1 04/2013
SBSM-0508-1 05/2013
SBSM-0608-1 06/2013
SBSM-0908-1 09/2013
SBSM-1008-1 10/2013 and
SBSM-1108-1 11/2013;
PNM-100 SBSM-1107-1 11/2012
SBSM-0408-1 04/2013
SBSM-0508-1 05/2013
SBSM-0608-1 06/2013
SBSM-0908-1 09/2013
SBSM-1008-1 10/2013 and
SBSM-1108-1 11/2013;
24-1010 (PNS-100) SBAL-1107-1 11/2012;
24-1215 (PNX-100) SBAL-1107-1 11/2012; and
24-1210 (PNM-100) SBAL-1107-1 11/2012.
|
Recalling Firm/
Manufacturer |
Stat Medical Devices, Inc.
2056 Ne 153rd St
Miami, Florida 33162-6020 |
| For Additional Information Contact |
Paul R. Fuller
978-774-1469
|
Reason for
Recall |
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.
|
| Action |
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. |
| Quantity in Commerce |
6,424,100 total pen needles |
| Distribution |
Worldwide Distribution -- US (CO and Puerto Rico), Canada, and Saudi Arabia. |
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