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U.S. Department of Health and Human Services

Class 2 Device Recall NOVAPLUS" GAMMEX NonLatex PI Green

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  Class 2 Device Recall NOVAPLUS" GAMMEX NonLatex PI Green see related information
Date Initiated by Firm August 03, 2023
Date Posted October 11, 2023
Recall Status1 Open3, Classified
Recall Number Z-0097-2024
Recall Event ID 93045
510(K)Number K111139  
Product Classification Surgeon's gloves - Product Code KGO
Product NOVAPLUS GAMMEX NON-LATEX PI GREEN Surgical gloves, REF: V20685255 through V20685290
Code Information Lot: 2203434604, REF/UDI-DI: V20685255/10014566400553, V20685260/10014566400607, V20685265/10014566400652, V20685270/10014566400706, V20685275/10014566400751, V20685280/10014566400805, V20685285/10014566400850, V20685290/10014566400904.
Recalling Firm/
Manufacturer		 Ansell Healthcare Products LLC
2301 Robb Dr
Reno NV 89523-1901
Manufacturer Reason
for Recall		 Some surgical glove sterile pouches were not completely sealed.
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.
Quantity in Commerce 378
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
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.
510(K) Database 510(K)s with Product Code = KGO and Original Applicant = ANSELL HEALTHCARE PRODUCTS, INC.
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