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Terminated

MICRO-TOUCH(R), S (indicating size small), NITRILE, Powder Free, Medical Examination Gloves, REF 6034301, 200 Pieces, Manufactured for: Ansell Healthcare - Made in Malaysia

FDA Recall Z-3114-2011 · Posted 2011-08-31

Recalling FirmAnsell Healthcare Products LLC
Recall StatusTerminated
Product CodeLZC
Date Initiated2011-08-04
Date Terminated2012-11-27
Product Quantity370 cases of 10

Reason for Recall

Gloves were inadvertently released for distribution prior to completion of testing required by the U.S. Food and Drug Administration.

Firm 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.

Root Cause

Release of Material/Component prior to receiving test results

Distribution Pattern

Nationwide distribution: NC, GA, IL, MO, LA, and PA

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K032374POWDER-FREE NITRILE PATIENT CHEMOTHERAPY EXAMINATION GLOVE, BLUE COLOREDPerusahaan Getah Asas Sdn. Bhd. · 2003-10-22

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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