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U.S. Department of Health and Human Services

Class 2 Device Recall AccuSure

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 Class 2 Recall
AccuSure
see related information
Date Posted June 24, 2009
Recall Status1 Terminated on November 01, 2010
Recall Number Z-1504-2009
Recall Event ID 51817
Product Classification Syringe, Piston - Product Code FMF
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
Manufacturer Reason
for Recall
Needles separate from the barrel of the syringes.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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