Z-1185-06

Sterile Triumph LT Latex Powder-Free Surgeons Gloves; 50 pairs of gloves per box, 4 boxes per carton...

Name: Z-1185-06 Sterile Triumph LT Latex Powder-Free Surgeons Gloves; 50 pairs of gloves per box, 4 boxes per carton...
Creator: Terang Nusa Sdn Bhd
Published: 2006-05-23
License: https://open.fda.gov/license/

Terang Nusa (Malaysia) Sdn. Bhd. / initiated 2006-05-23 / Terminated / root cause: packaging

FDA source

Terang Nusa Sdn Bhd began a recall of 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... on 2006-05-23. The reason FDA records is "The sterile glove pouches may have an open seal at the bottom of the pouch". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1185-06
Status: Terminated
Initiated: 2006-05-23
Posted: 2006-06-27
Terminated: 2007-01-22
Recalling firm: Terang Nusa (Malaysia) 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
Product code: KGO Surgeon'S Gloves
Reason for recall: The sterile glove pouches may have an open seal at the bottom of the pouch.
Root cause tag: packaging
FDA 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 in commerce: 51 cartons
Distribution: Nationwide
Product codes and lots: Item number MDS108070LT, lot number T502504322, size 7

Product code KGO

K982957Class ISensiflex Powderfree Surgeon's GloveTerang Nusa Sdn Bhd / cleared 1999-01-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)