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.
FDA Recall Z-1596-2009 · Posted 2009-07-24
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Recalling FirmStat Medical Devices, Inc.
Recall StatusTerminated
Product CodeFMI
Date Initiated2009-05-29
Date Terminated2010-09-07
Product Quantity6,424,100 total pen needles
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.
Firm 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.
Root Cause
PMA
Distribution Pattern
Worldwide Distribution -- US (CO and Puerto Rico), Canada, and Saudi Arabia.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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