FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-1046-03
- 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.
- Status
- Terminated
- Initiated
- 2003-06-27
- Posted
- 2003-07-24
- Terminated
- 2003-11-25
- 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.
- Lot, serial or model codes
- Reorder No. 8878. All lots distributed between May 28, 2003 and July 9, 2003.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LYY
- Firm FEI
- 1000522050
- Firm city
- Melville
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28