Sterile Triumph LT Latex Powder-Free Surgeons Gloves; 50 pairs of gloves per box, 4 boxes per carton; Manufactured for M
FDA device recall Z-1185-06 · posted 2006-06-27 · Terminated
Recall details
- Recalling firm
- Terang Nusa Sdn Bhd
- Reason for recall
- The sterile glove pouches may have an open seal at the bottom of the pouch.
- Action taken
- 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 fax it back to Medline at 847-949-2643 to obtain a return goods authorization. Any questions were directed to Kathy Dunne at 847-970-4678.
- Root cause
- Other
- Status
- Terminated
- Product code
- KGO
- Quantity affected
- 51 cartons
- Distribution
- Nationwide
- Date initiated
- 2006-05-23
- Date posted
- 2006-06-27
- Date terminated
- 2007-01-22
- Location
- Kota Bharu, Malaysia
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SENSIFLEX POWDERFREE SURGEON'S GLOVE (K982957) | Terang Nusa Sdn Bhd | 1999-01-13 |