Z-3117-2011

MICRO-TOUCH(R), XL (indicating size extra large), NITRILE, Powder Free, Medical Examination Gloves, REF...

Name: Z-3117-2011 MICRO-TOUCH(R), XL (indicating size extra large), NITRILE, Powder Free, Medical Examination Gloves, REF...
Creator: Ansell Healthcare Products LLC
Published: 2011-08-04
License: https://open.fda.gov/license/

Ansell Healthcare Products LLC / initiated 2011-08-04 / Terminated

FDA source

Ansell Healthcare Products LLC began a recall of MICRO-TOUCH(R), XL (indicating size extra large), NITRILE, Powder Free, Medical Examination Gloves, REF 6034304, 200 Pieces, Manufactured for: Ansell... on 2011-08-04. The reason FDA records is "Gloves were inadvertently released for distribution prior to completion of testing required by the U.S. Food and Drug Administration". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-3117-2011
Status: Terminated
Initiated: 2011-08-04
Posted: 2011-08-31
Terminated: 2012-11-27
Recalling firm: Ansell Healthcare Products LLC
Product: MICRO-TOUCH(R), XL (indicating size extra large), NITRILE, Powder Free, Medical Examination Gloves, REF 6034304, 200 Pieces, Manufactured for: Ansell Healthcare - Made in Malaysia
Product code: LZC Medical Glove, Specialty
Reason for recall: Gloves were inadvertently released for distribution prior to completion of testing required by the U.S. Food and Drug Administration.
FDA 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 in commerce: 122 cases of 10
Distribution: Nationwide distribution: NC, GA, IL, MO, LA, and PA
Product codes and lots: 11040195EP

Product code LZC

K032374Class IPowder-Free Nitrile Patient Chemotherapy Examination Glove, Blue ColoredPerusahaan Getah Asas Sdn. Bhd. / cleared 2003-10-22

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)