Z-0051-2021 Class II Terminated
FDA device recall Z-0051-2021 was initiated by Ansell Healthcare Products LLC on August 19, 2020 and is designated Class II. Reason for recall: Examination gloves were shipped inadvertently, without to verify barrier integrity. The recall status is terminated (terminated November 3, 2021). Affected quantity: 1312 Cases.
Recall Details
- Product Type
- Devices
- Report Date
- October 14, 2020
- Initiation Date
- August 19, 2020
- Termination Date
- November 3, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1312 Cases
Product Description
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 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.
Code Information
Lot: 2003LG, Batch: 20035314LG