Sterile Neolon 2G Latex-Free Powder-Free Neoprene Surgical Gloves, Does Not Contain Natural Rubber Latex; 1 pair of glov
FDA device recall Z-0365-2007 · posted 2007-01-25 · Terminated
Recall details
- Recalling firm
- Terang Nusa Sdn Bhd
- Reason for recall
- Some of the packages labeled as latex-free actually contain latex gloves.
- Action taken
- 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
- Status
- Terminated
- Product code
- KGO
- Quantity affected
- 43 cases
- Distribution
- Worldwide including USA, Canada, and Panama
- Date initiated
- 2006-12-18
- Date posted
- 2007-01-25
- Date terminated
- 2009-08-12
- Location
- Kota Bharu, Malaysia
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NUZONE X2A NEOPRENE - POLYISOPRENE POWDER FREE SURGICAL GLOVES POLYMER AND ALOE COATED (K051563) | Terang Nusa Sdn Bhd | 2005-06-20 |