Atlas FDA

Positive Touch (TM) TEXTURED POWDER-FREE LATEX EXAM GLOVES, LARGE. REORDER NO. 8843. Single Use Only. Qty. 100 Per Box (

FDA device recall Z-1045-03 · posted 2003-07-24 · Terminated

Recall details

Recalling firm
Henry Schein, Inc.
Reason for recall
FDA's analysis revealed defects (holes) in the latex gloves.
Action taken
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.
Root cause
Other
Status
Terminated
Product code
LYY
Quantity affected
56 boxes (100 gloves per box)
Distribution
18 end users in NY, NJ, PA, MA, CT, NH, ME, MD, VA.
Date initiated
2003-06-27
Date posted
2003-07-24
Date terminated
2003-11-25
Location
Melville, NY

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