FDA Device

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.

Hazard

FDA's analysis revealed defects (holes) in the latex gloves.

What You Should Do

Remedy

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.

Products

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 M
Brand
Henry Schein, Inc.
UPC
Reorder No. 8843; All lots distributed between May 28, 2003 and July 9, 2003, including Lot # 4E02A021.

Units Affected

56 boxes (100 gloves per box)