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U.S. Department of Health and Human Services

Class 2 Device Recall MICROFLEX Diamond Grip Examination Gloves

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  Class 2 Device Recall MICROFLEX Diamond Grip Examination Gloves see related information
Date Initiated by Firm August 19, 2020
Create Date October 02, 2020
Recall Status1 Terminated 3 on November 03, 2021
Recall Number Z-0051-2021
Recall Event ID 86352
510(K)Number K974424  
Product Classification Latex patient examination glove - Product Code LYY
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.
Code Information Lot: 2003LG, Batch: 20035314LG
Recalling Firm/
Manufacturer		 Ansell Healthcare Products LLC
2301 Robb Dr
Reno NV 89523-1901
For Additional Information Contact Tammy McGriff
334-615-2566
Manufacturer Reason
for Recall		 Examination gloves were shipped inadvertently, without to verify barrier integrity.
FDA Determined
Cause 2		 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 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.
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LYY and Original Applicant = COMFORT RUBBER GLOVES INDUSTRIES SDN BHD
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