FDA Medical Device Recalls (openFDA)
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
- Recall number
- Z-1185-06
- Recalling firm
- Terang Nusa Sdn Bhd
- Product
- 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
- Status
- Terminated
- Initiated
- 2006-05-23
- Posted
- 2006-06-27
- Terminated
- 2007-01-22
- 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 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.
- Quantity
- 51 cartons
- Distribution
- Nationwide
- Lot, serial or model codes
- Item number MDS108070LT, lot number T502504322, size 7
- 510(k) numbers
- ["K982957"]
- 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