Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1045-03

Positive Touch (TM) TEXTURED POWDER-FREE LATEX EXAM GLOVES, LARGE. REORDER NO. 8843. Single Use Only. Qty...

Henry Schein, Inc. / initiated 2003-06-27 / Terminated

Henry Schein, Inc. began a recall of 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... on . The reason FDA records is "FDA's analysis revealed defects (holes) in the latex gloves". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-1045-03
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Henry Schein, Inc.
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.
Product code
LYY Latex Patient Examination Glove
Reason for recall
FDA's analysis revealed defects (holes) in the latex gloves.
FDA root 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.
Product codes and lots
Reorder No. 8843; All lots distributed between May 28, 2003 and July 9, 2003, including Lot # 4E02A021.