Class 2 Device Recall Positive Touch

• Date Initiated by Firm: June 27, 2003
• Date Posted: July 24, 2003
• Recall Status: Terminated on November 25, 2003
• Recall Number: Z-1045-03
• Recall Event ID: 26594
• Product Classification: Latex Patient Examination Glove - Product Code LYY
• 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
• For Additional Information Contact: Sergio Tejeda; 631-843-5546
• Manufacturer Reason for Recall: FDA's analysis revealed defects (holes) in the latex gloves.
• FDA Determined Cause: 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

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.