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Recall Observatory FDA recall evidence

Device product

MICROFLEX Diamond Grip Examination Gloves, MF-300 - Product Usage: A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner s hand or finger to prevent contamination between patient and examiner.

Z-0051-2021

August 19, 2020

Class II

Product summary

Firm
Ansell Healthcare Products LLC
Event
Event 86352
Status
Terminated
Classification
Class II
Quantity
1312 Cases
Official record key
device-enforcement:Z-0051-2021

Official wording

Reason: Examination gloves were shipped inadvertently, without to verify barrier integrity.

Code information: Lot: 2003LG, Batch: 20035314LG

Distribution pattern: U.S. Nationwide distribution including in the states of IL, OK, WI, PA, TX, OH, MI, IN, VA, AR, KS, MO, NV, OR, FL, QC, NJ, NE, KY, AL, TN, LA, NY, SC, MS, MD, CA, GA, SD.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Examination gloves were shipped inadvertently, without to verify barrier integrity.