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Terminated

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

FDA Recall Z-0365-2007 · Posted 2007-01-25

Recalling FirmTerang Nusa Sdn Bhd
Recall StatusTerminated
Product CodeKGO
Date Initiated2006-12-18
Date Terminated2009-08-12
Product Quantity43 cases

Reason for Recall

Some of the packages labeled as latex-free actually contain latex gloves.

Firm 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.

Root Cause

Other

Distribution Pattern

Worldwide including USA, Canada, and Panama

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K051563NUZONE X2A NEOPRENE - POLYISOPRENE POWDER FREE SURGICAL GLOVES POLYMER AND ALOE COATEDTerang Nusa Sdn Bhd · 2005-06-20

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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