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U.S. Department of Health and Human Services

Class 2 Device Recall Positive Touch

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 Class 2 Device Recall Positive Touchsee related information
Date Initiated by FirmJune 27, 2003
Date PostedJuly 24, 2003
Recall Status1 Terminated 3 on November 25, 2003
Recall NumberZ-1046-03
Recall Event ID 26594
Product Classification Latex Patient Examination Glove - Product Code LYY
ProductPositive Touch (TM) SMOOTH POWDER-FREE LATEX EXAM GLOVES, LARGE. REORDER NO. 8878. 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. 8878. All lots distributed between May 28, 2003 and July 9, 2003.
Recalling Firm/
Manufacturer		 Henry Schein, Inc.
135 Duryea Road
Melville NY 11747
For Additional Information ContactSergio Tejeda
631-843-5546
Manufacturer Reason
for Recall		FDA's analysis revealed defects (holes) in the latex gloves.
FDA Determined
Cause 2		Other
ActionRecall 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 Commerce40 boxes (100 gloves per box)
Distribution18 end users in NY, NJ, PA, MA, CT, NH, ME, MD, VA.
Total Product Life CycleTPLC 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.
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