Z-1596-2009

Stat (TM) Super-Fine (TM) Pen Needles and Allison Medical, Inc. Sure Comfort Pen Needles with Silicone Tip...

Name: Z-1596-2009 Stat (TM) Super-Fine (TM) Pen Needles and Allison Medical, Inc. Sure Comfort Pen Needles with Silicone Tip...
Creator: Stat Medical Devices, Inc.
Published: 2009-05-29
License: https://open.fda.gov/license/

Stat Medical Devices, Inc. / initiated 2009-05-29 / Terminated

FDA source

Stat Medical Devices, Inc. began a recall of 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... on 2009-05-29. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1596-2009
Status: Terminated
Initiated: 2009-05-29
Posted: 2009-07-24
Terminated: 2010-09-07
Recalling firm: Stat Medical Devices, Inc.
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.
Product code: FMI Needle, Hypodermic, Single Lumen
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.
FDA root cause: PMA
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.
Product codes and lots: 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.

Product code FMI

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)