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Class 2 Device Recall GAMMEX NonLatex PI Green |
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Date Initiated by Firm |
August 03, 2023 |
Date Posted |
October 11, 2023 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-0096-2024 |
Recall Event ID |
93045 |
510(K)Number |
K111139
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Product Classification |
Surgeon's gloves - Product Code KGO
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Product |
GAMMEX NON-LATEX PI GREEN Surgical gloves, REF: 20685255 through 20685290 |
Code Information |
Lot: 2203434204, REF/UDI-DI:
20685255/00884792385206,
20685260/00884792385213,
20685265/00884792385220,
20685270/00884792385237,
20685275/00884792385244,
20685280 00884792385251,
20685285 00884792385268,
20685290 00884792385275.
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Recalling Firm/ Manufacturer |
Ansell Healthcare Products LLC 2301 Robb Dr Reno NV 89523-1901
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Manufacturer Reason for Recall |
Some surgical glove sterile pouches were not completely sealed.
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FDA Determined Cause 2 |
Process control |
Action |
On 8/3/23, recall notices were mailed or emailed to customers and distributors. Customers who did not respond were contacted via phone. Customers and distributors were asked to do the following:
1) Communicate with all personnel that utilize the product of the risk of and need to discontinue use of the impacted products.
2) Complete the customer Response Form at http://www.novasyte.com/ansell/capa-296-2023 and
3) Return impacted product. If impacted product was purchased from a distributor, contact your distributor directly for further instructions and replacement products.
Customers with questions can call 1-800-952-9916 or email CustomerServiceUS@Ansell.com
In addition, distributors were asked to take every effort to communicate the recall situation to their impacted End-User customers that received this product. We recommend that distributors attempt to contact and notify each customer at least three times by e-mail and/or by phone. See end-user customer letters. Please contact Novasyte with questions via email ansell-capa-296-2023@iqvia.com or at (855) 558-2741.
visit http://www.novasyte.com/ansell/capa-296-2023 to complete the necessary acknowledgement form
If you have questions on this notification, please reach out directly via CustomerServiceUS@Ansell.com or 1-800-952-9916.
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Quantity in Commerce |
1511 |
Distribution |
Worldwide - US Nationwide distribution in the states of IN, OH, NY, VA, IL, TN, GA, NY, SC, WI, FL and the country of CA. |
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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510(K) Database |
510(K)s with Product Code = KGO and Original Applicant = ANSELL HEALTHCARE PRODUCTS, INC.
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