FDA recall Z-0051-2021

Ansell Healthcare Products LLC · Class II · 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.

Reason for recall

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

Distribution

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.

Key facts

Status
Terminated
Initiation date
2020-08-19
Report date
2020-10-14
Termination date
2021-11-03
Voluntary/Mandated
Voluntary: Firm initiated
Location
Reno, NV, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0051-2021