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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 2 Recall
AccuSure		see related information
Date Posted June 24, 2009
Recall Number Z-1504-2009
Product AccuSure, U-100 31 Gauge, 1cc Insulin Syringe, 5/16" (8mm) Needles, Short Needle, packaged 10 syringes per package, 10 packages per carton, NDC 0603-7002-2
Code Information Lot A07001, exp 07/2012
Recalling Firm/
Manufacturer		 Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals
120 Vintage Dr Ne
Huntsville, Alabama 35811-8216
For Additional Information Contact Mr. Larry Kass
256-859-2222
Reason for
Recall		 Needles separate from the barrel of the syringes.
Action On 04/09/2009, Qualitest issued a press release and sent out recall notifications to their consignees by US Mail. The recall was extended to the User level. Qualitest will send a second letter to all non-responders after thirty days. Thirty days after the second letter, Qualitest will perform a recall effectiveness check by telephone on a percentage of non-responders (in accordance with FDA request).
Quantity in Commerce 559,500 syringes
Distribution Nationwide.
 
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