Recall Z-0051-2021 ยท LYY Latex Patient Examination Glove
Ansell Healthcare Products LLC
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.
| Date | Aug 19, 2020 |
| Status | Terminated |
| Reason | Examination gloves were shipped inadvertently, without to verify barrier integrity. |
| Root cause | Under Investigation by firm |
| Action | On 08/19/2020, recall notices were emailed to customers who were asked to do the following: If you believe you may have received affected product, please visit: http://www.novasyte.com/ansell/capa-206-2020 to complete the necessary acknowledgement form. Upon completion of the acknowledgement form, Ansell will partner with you to arrange for a return of the product, provide a credit, and offer you the option of a reship. For any assistance regarding the acknowledgement form, please contact Novasyte at 855-863-7288 or ansell-capa-206-2020@novasyte.com Novasyte emailed E-Mail/ Letter for Distrib |
| Quantity | 1312 Cases |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K974424 | COMFORT RUBBER GLOVES INDUSTRIES SDN BHD Comfort Rubber Gloves Industries Sdn. Bhd., Apr 23, 1998 |