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U.S. Department of Health and Human Services

Class 2 Device Recall Gammex

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 Class 2 Device Recall Gammexsee related information
Date Initiated by FirmOctober 24, 2016
Create DateDecember 22, 2016
Recall Status1 Terminated 3 on October 23, 2017
Recall NumberZ-0893-2017
Recall Event ID 75737
510(K)NumberK984558 
Product Classification Surgeon's gloves - Product Code KGO
ProductGammex Non-Latex Sensitive Neoprene Surgical Gloves Ansell Lanka (pvt) Ltd. Biyagama Export Processing Zone, Biyagama, Sri Lanka Ansell Healthcare Europe, N.V Internationaleiaan 55, 1070 Brussels, Belgium Manufactured for/ Fabrique' pour: Ansell Healthcare products LLC. 1635 Industrial Road Dothan, AL 36303, USA TEL USA- 1-800-952-9916 CAN- 1-844-494-7854 catalog #20277285
Code Information Lot 1607018105
Recalling Firm/
Manufacturer		 Ansell Healthcare Products LLC
111 Wood Ave S Ste 210
Iselin NJ 08830-2700
For Additional Information Contact
1800-952-9916
Manufacturer Reason
for Recall		Ansell Healthcare Products is initiating a voluntary recall involving 15 cases of Gammex Non Latex Sensitive Surgical Gloves because the packaged contents incorrectly included a natural rubber Latex surgical glove.
FDA Determined
Cause 2		Packaging change control
ActionAnsell Healthcare Products, LLC. sent an Urgent: Voluntary Surgical Glove Recall letter dated October 28, 2016, to all affected customers. The letter identified the problem the product and the action the customer needs to take. Please check your product stock at the warehouse and shelf level in order to advise us directly if any gloves having the recalled lot numbers are found. This information, along with your tracking number, must be communicated to our Customer Service Department by calling 1-800-952-9916, or by returning the attached Response Form to Ansell by fax at 1-800-722-8155, or via email customerserviceus@ansell.com . Returned product will either be replaced or credited without delay. Your Ansell representative will be available to follow up with you regarding any concerns you may have.
Quantity in Commerce15 Cartons
DistributionUS Distribution to the states of : PA, FL, NJ, IL and MA.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = KGO
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