Recall Z-1046-03 ยท LYY Latex Patient Examination Glove
Henry Schein, Inc.
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.
| Date | Jul 24, 2003 (initiated Jun 27, 2003) |
| Status | Terminated |
| Reason | FDA's analysis revealed defects (holes) in the latex gloves. |
| 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 | 40 boxes (100 gloves per box) |
| Distribution | 18 end users in NY, NJ, PA, MA, CT, NH, ME, MD, VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.