Device Recall Stat (TM) SuperFine (TM) Pen Needles and Allison Medical, Inc. Sure Comfort Pen Needles

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.

General Hospital and Personal Use Devices

2

No

Worldwide Distribution -- US (CO and Puerto Rico), Canada, and Saudi Arabia.

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.