| Class 2 Device Recall Neolon 2G LatexFree PowderFree Neoprene Surgical Gloves | |
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
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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
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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 |
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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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = KGO
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