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U.S. Department of Health and Human Services

Class 2 Device Recall Stat (TM) SuperFine (TM) Pen Needles and Allison Medical, Inc. Sure Comfort Pen Needles

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  Class 2 Device Recall Stat (TM) SuperFine (TM) Pen Needles and Allison Medical, Inc. Sure Comfort Pen Needles see related information
Date Initiated by Firm May 29, 2009
Date Posted July 24, 2009
Recall Status1 Terminated 3 on September 07, 2010
Recall Number Z-1596-2009
Recall Event ID 52159
Product Classification Pen Needles - Product Code FMI
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 FL 33162-6020
For Additional Information Contact Paul R. Fuller
978-774-1469
Manufacturer 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 Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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