FDA Medical Device Recalls (openFDA)
Ansell Healthcare Products LLC: MICRO-TOUCH(R), M (indicating size medium), NITRILE, Powder Free, Medical Examination Gloves, REF 6034302, 200 Pieces, Manufactured for: Ansell Healthcare - Made in Malaysia
- Recall number
- Z-3115-2011
- Recalling firm
- Ansell Healthcare Products LLC
- Product
- MICRO-TOUCH(R), M (indicating size medium), NITRILE, Powder Free, Medical Examination Gloves, REF 6034302, 200 Pieces, Manufactured for: Ansell Healthcare - Made in Malaysia
- Status
- Terminated
- Initiated
- 2011-08-04
- Posted
- 2011-08-31
- Terminated
- 2012-11-27
- Reason
- Gloves were inadvertently released for distribution prior to completion of testing required by the U.S. Food and Drug Administration.
- Root cause
- Release of Material/Component prior to receiving test results
- Action
- Ansell account managers were notified on August 4, 2011 to contact (by phone, fax, e-mail) their respective accounts and notify them of the recall situation. The Ansell account managers were provided with a copy of the recall notification to provide to their accounts. The recall notification includes a request that if these gloves have been further distributed to other customers, please advise them of the recall situation and have them return any outstanding stocks.
- Quantity
- 700 cases of 10
- Distribution
- Nationwide distribution: NC, GA, IL, MO, LA, and PA
- Lot, serial or model codes
- 11040193EP
- 510(k) numbers
- ["K032374"]
- PMA numbers
- not on file
- Product code
- LZC
- Firm FEI
- 1019632
- Firm city
- Dothan
- Firm state
- AL
- 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