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Class 2 Device Recall Positive Touch |
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Date Initiated by Firm |
June 27, 2003 |
Date Posted |
July 24, 2003 |
Recall Status1 |
Terminated 3 on November 25, 2003 |
Recall Number |
Z-1045-03 |
Recall Event ID |
26594 |
Product Classification |
Latex Patient Examination Glove - Product Code LYY
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Product |
Positive Touch (TM) TEXTURED POWDER-FREE LATEX EXAM GLOVES, LARGE. REORDER NO. 8843. Single Use Only. Qty. 100 Per Box (50 pairs), 1000 Per Case.
Firm on Label: Allegiance Healthcare Corporation McGraw Park, IL 60085 USA. Allegiance, a Cardinal Health company. Made in Malaysia. |
Code Information |
Reorder No. 8843; All lots distributed between May 28, 2003 and July 9, 2003, including Lot # 4E02A021. |
Recalling Firm/ Manufacturer |
Henry Schein, Inc. 135 Duryea Road Melville NY 11747
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For Additional Information Contact |
Sergio Tejeda 631-843-5546
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Manufacturer Reason for Recall |
FDA's analysis revealed defects (holes) in the latex gloves.
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FDA Determined Cause 2 |
Other |
Action |
Recall letters were faxed to the 5 end users on 6/27/03. This was followed up with phone calls to the 5 end users. Recall letters were faxed and mailed to all 18 end users on 7/10/03, advising them of the recall expansion. |
Quantity in Commerce |
56 boxes (100 gloves per box) |
Distribution |
18 end users in NY, NJ, PA, MA, CT, NH, ME, MD, VA. |
Total Product Life Cycle |
TPLC Device Report
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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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