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U.S. Department of Health and Human Services

Class 2 Device Recall Neolon 2G LatexFree PowderFree Neoprene Surgical Gloves

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  Class 2 Device Recall Neolon 2G LatexFree PowderFree Neoprene Surgical Gloves see related information
Date Initiated by Firm December 18, 2006
Date Posted January 25, 2007
Recall Status1 Terminated 3 on August 12, 2009
Recall Number Z-0365-2007
Recall Event ID 37013
510(K)Number K051563  
Product Classification surgical gloves - Product Code KGO
Product Sterile Neolon 2G Latex-Free Powder-Free Neoprene Surgical Gloves, Does Not Contain Natural Rubber Latex; 1 pair of gloves per package, 100 packages per case; Manufactured for Medline Industries, Inc., Mundelein, IL 60060 U.S.A., Made in Malaysia
Code Information Item number MDS207060, lot number T502554397, size 6
Recalling Firm/
Manufacturer		 Terang Nusa Sdn Bhd
1, Jalan 8, Pengkalan Chepa 2, Ind Zone
Kota Bharu Malaysia
Manufacturer Reason
for Recall		 Some of the packages labeled as latex-free actually contain latex gloves.
FDA Determined
Cause 2		 Other
Action Terang Nusa telephoned Medline Industries on 12/13/06 requesting them to retrieve the affected lot of size six gloves from their customers. Medline Industries notified their customers by letter dated 12/20/06, informing them of the possible latex gloves being labeled as the Neolon 2G Neoprene Surgical Gloves, and requesting them to inspect their inventories for the suspect size and lot of gloves. The accounts were instructed to complete the enclosed response questionnaire, indicating the amount of affected gloves found, and fax it back to Medline at 847-949-2643 to obtain a return goods authorization. Any questions were directed to Kathy Dunne at 847-359-1704.
Quantity in Commerce 43 cases
Distribution Worldwide including USA, Canada, and Panama
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KGO and Original Applicant = TERANG NUSA SDN BHD
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