FDA Recall
Terminated
Positive 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.
Recall: Z-1046-03
·
Initiated June 27, 2003
Recall
- Recall Number
- Z-1046-03
- Event Number
- 26594
- Firm
- Henry Schein, Inc.
- FEI Number
- 1000522050
- Product Code
- LYY
- Status
- Terminated
- Root Cause
- Other
- Initiated
- June 27, 2003
- Posted
- July 24, 2003
- Terminated
- November 25, 2003
- Address
- 135 Duryea Road, Melville, NY, 11747
Description
Positive 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.
Reason
FDA's analysis revealed defects (holes) in the latex gloves.
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.
Distribution
18 end users in NY, NJ, PA, MA, CT, NH, ME, MD, VA.
Quantity
40 boxes (100 gloves per box)