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U.S. Department of Health and Human Services

Class 2 Device Recall Gammex NonLatex

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  Class 2 Device Recall Gammex NonLatex see related information
Date Initiated by Firm February 19, 2022
Create Date March 30, 2022
Recall Status1 Open3, Classified
Recall Number Z-0838-2022
Recall Event ID 89691
510(K)Number K111139  
Product Classification Surgeon's gloves - Product Code KGO
Product Gammex Non-Latex PI Green PI-KARE Skin-friendly PI Technology polyisoprene surgical gloves 7 1/2
Code Information Model Number: 20685275 UDI Code: 00884792385244 Lot Number: 2107481604
Recalling Firm/
Manufacturer		 Ansell Healthcare Products LLC
2301 Robb Dr
Reno NV 89523-1901
For Additional Information Contact Tammy McGriff
334-470-7106
Manufacturer Reason
for Recall		 Transport company failed to stop at the border for required FDA inspection.
FDA Determined
Cause 2		 Other
Action On 02/19/2022, the Recalling Firm initiated notification via email to its Distribution partners and requested that they reach out to their end user customers. The Recalling Firm informed its customers that between February 2nd to 10th, 2022, it shipped Non-Latex surgical gloves with LOT Number 2107481604 and Manufacturing Date 2021-08-05 to some of its distributor partners. As a part of their warehouse inventory rebalancing procedures within North America, the product was transferred from their Canadian warehouse to one of their USA warehouses. When importing into the US, the freight forwarder inadvertently bypassed a required FDA inspection. After arriving at the USA warehouse, product was shipped prematurely. Customers/Distributors are asked to: 1. Search their system/inventory to identify if affected products are currently in their possession. A visual guide is provided to assist with identifying the impacted product. 2. If impacted products are found in their system/inventory, they are to return the impacted products back to the Recalling Firm, and replacements were be provided free of charge. For questions or assistance in returning the products, contact Customer Service at 1-855-868-5540 or email customersolutionsus@ansell.com.
Quantity in Commerce 74 cases
Distribution U.S.: AZ, CA, NV, TX, UT and WA O.U.S.: None
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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