FDA Medical Device Recalls (openFDA)
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
- Recall number
- Z-0365-2007
- Recalling firm
- Terang Nusa Sdn Bhd
- 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
- Status
- Terminated
- Initiated
- 2006-12-18
- Posted
- 2007-01-25
- Terminated
- 2009-08-12
- 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 authorization. Any questions were directed to Kathy Dunne at 847-359-1704.
- Quantity
- 43 cases
- Distribution
- Worldwide including USA, Canada, and Panama
- Lot, serial or model codes
- Item number MDS207060, lot number T502554397, size 6
- 510(k) numbers
- ["K051563"]
- PMA numbers
- not on file
- Product code
- KGO
- Firm FEI
- 3012304897
- Firm city
- Kota Bharu
- Firm state
- not on file
- Firm country
- Malaysia
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28