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.
- Company
- Ansell Healthcare Products Llc
- Recall Initiated
- August 19, 2020
- Terminated
- November 3, 2021
- Recall Number
- Z-0051-2021
- Quantity
- 1312 Cases
- Firm Location
- Reno, NV
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.
Lot / Code Info
Lot: 2003LG, Batch: 20035314LG
Root Cause
Under Investigation by firm
Action Taken
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 Distributors to Send End-User Customers, Dated 08/18/20, to distributors informing them to send this letter to the end users. End users were asked to return affected products to distributors. On 08/21/2020, the firm followed up with customers via phone.