• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Neolon 2G LatexFree PowderFree Neoprene Surgical Gloves

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Neolon 2G LatexFree PowderFree Neoprene Surgical Glovessee related information
Date Initiated by FirmDecember 18, 2006
Date PostedJanuary 25, 2007
Recall Status1 Terminated 3 on August 12, 2009
Recall NumberZ-0365-2007
Recall Event ID 37013
510(K)NumberK051563 
Product Classification surgical gloves - Product Code KGO
ProductSterile 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
Code Information Item number MDS207060, lot number T502554397, size 6
Recalling Firm/
Manufacturer
Terang Nusa Sdn Bhd
1, Jalan 8, Pengkalan Chepa 2, Ind Zone
Kota Bharu Malaysia
Manufacturer Reason
for Recall
Some of the packages labeled as latex-free actually contain latex gloves.
FDA Determined
Cause 2
Other
ActionTerang 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 in Commerce43 cases
DistributionWorldwide including USA, Canada, and Panama
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
-
-