Z-1046-03

Positive Touch (TM) SMOOTH POWDER-FREE LATEX EXAM GLOVES, LARGE. REORDER NO. 8878. Single Use Only. Qty. 100...

Name: Z-1046-03 Positive Touch (TM) SMOOTH POWDER-FREE LATEX EXAM GLOVES, LARGE. REORDER NO. 8878. Single Use Only. Qty. 100...
Creator: Henry Schein, Inc.
Published: 2003-06-27
License: https://open.fda.gov/license/

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

FDA source

Henry Schein, Inc. began a recall of 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 -... on 2003-06-27. The reason FDA records is "FDA's analysis revealed defects (holes) in the latex gloves". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1046-03
Status: Terminated
Initiated: 2003-06-27
Posted: 2003-07-24
Terminated: 2003-11-25
Recalling firm: Henry Schein, Inc.
Product: 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.
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: 40 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. 8878. All lots distributed between May 28, 2003 and July 9, 2003.

Product code LYY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)