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Class 2 Device Recall MICROFLEX Diamond Grip Examination Gloves |
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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
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Product Classification |
Latex patient examination glove - Product Code LYY
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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
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For Additional Information Contact |
Tammy McGriff 334-615-2566
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Manufacturer Reason for Recall |
Examination gloves were shipped inadvertently, without to verify barrier integrity.
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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
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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.
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510(K) Database |
510(K)s with Product Code = LYY and Original Applicant = COMFORT RUBBER GLOVES INDUSTRIES SDN BHD
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