Recall Z-1185-06 ยท KGO Surgeon'S Gloves
Terang Nusa Sdn Bhd
Sterile Triumph LT Latex Powder-Free Surgeons Gloves; 50 pairs of gloves per box, 4 boxes per carton; Manufactured for Medline Industries, Inc., Mundelein, IL 60060 U.S.A., Made in Malayia
| Date | Jun 27, 2006 (initiated May 23, 2006) |
| Status | Terminated |
| Reason | The sterile glove pouches may have an open seal at the bottom of the pouch. |
| Root cause | Other |
| Action | Terang Nusa notified Medline Industries via letters dated 5/23/06 and 5/26/06 to cease distribution of the gloves due to the defective seals on the pouches, and retrieve the affected lot of size seven gloves from their customers. Medline Industries notified their customers by letter dated 6/1/06, informing them of the possible open seals on the packages of surgeon''s 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 fa |
| Quantity | 51 cartons |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K982957 | SENSIFLEX POWDERFREE SURGEON'S GLOVE Terang Nusa Sdn Bhd, Jan 13, 1999 |