Recall Z-0365-2007
Terang Nusa Sdn Bhd · initiated December 18, 2006
Product
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
Codes / lots: Item number MDS207060, lot number T502554397, size 6
Reason for recall
Some of the packages labeled as latex-free actually contain latex gloves.
FDA-determined cause: Other
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.
Details
- Recall number
- Z-0365-2007
- Initiated
- December 18, 2006
- Posted by FDA
- January 25, 2007
- Terminated
- August 12, 2009
- Product code
- KGO – Surgeon'S Gloves
- Quantity
- 43 cases
- Distribution
- Worldwide including USA, Canada, and Panama
- Recalling firm
- Terang Nusa Sdn Bhd, Kota Bharu