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U.S. Department of Health and Human Services

Class 2 Device Recall Triumph LT Surgical Gloves

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 Class 2 Device Recall Triumph LT Surgical Glovessee related information
Date Initiated by FirmMay 23, 2006
Date PostedJune 27, 2006
Recall Status1 Terminated 3 on January 22, 2007
Recall NumberZ-1185-06
Recall Event ID 35609
510(K)NumberK982957 
Product Classification Surgeon'S Gloves - Product Code KGO
ProductSterile 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
Code Information Item number MDS108070LT, lot number T502504322, size 7
FEI Number 3012304897
Recalling Firm/
Manufacturer		 Terang Nusa Sdn Bhd
1, Jalan 8, Pengkalan Chepa 2, Ind Zone
Kota Bharu Malaysia
Manufacturer Reason
for Recall		The sterile glove pouches may have an open seal at the bottom of the pouch.
FDA Determined
Cause 2		Other
ActionTerang 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 Commerce51 cartons
DistributionNationwide
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = KGO
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