Recall Z-0365-2007 ยท KGO Surgeon'S Gloves
Terang Nusa Sdn Bhd
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
| Date | Jan 25, 2007 (initiated Dec 18, 2006) |
| Status | Terminated |
| Reason | Some of the packages labeled as latex-free actually contain latex gloves. |
| Root cause | 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 author |
| Quantity | 43 cases |
| Distribution | Worldwide including USA, Canada, and Panama |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051563 | NUZONE X2A NEOPRENE - POLYISOPRENE POWDER FREE SURGICAL GLOVES POLYMER AND ALOE COATED Terang Nusa Sdn Bhd, Jun 20, 2005 |