Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Zee Clear Vinyl Medical Examination Gloves, Large

  • 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 Zee Clear Vinyl Medical Examination Gloves, Large see related information
Date Initiated by Firm November 15, 2011
Date Posted January 11, 2012
Recall Status1 Terminated 3 on October 08, 2012
Recall Number Z-0680-2012
Recall Event ID 60552
510(K)Number K093264  
Product Classification Vinyl patient examination glove - Product Code LYZ
Product Zee Clear Vinyl Medical Examination Gloves, Powder Free, Large, Non-Sterile; 100 gloves per box, 10 boxes per case; Distributed by Zee Medical, Inc., Irvine, CA 92606, Made in China; Zee Part No.: 3062

Single Use, medical exam glove worn on the hand to provide a barrier against potentially infectious materials and other contaminants
Code Information Zee Part No.: 3062, lot number CZA04-22
Recalling Firm/
Manufacturer		 Cypress Medical Products LLC
1202 S Il Route 31
Mchenry IL 60050
For Additional Information Contact Mr. Alex Nagy
815-385-0100
Manufacturer Reason
for Recall		 The gloves fail to meet the performance requirements of 21 CFR 800.20 for leakage defects.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Cypress Medical telephoned the accounts and then sent Urgent Voluntary Medical Device Recall letters dated November 14, 2011, to all affected customers. The letter informed them that the lot of gloves did not meet certain release specifications and that some of the gloves may not provide an effective barrier to infectious material. Customers were requested to cease distribution of the affected product, quarantine the gloves, and contact Cypress Medical's customer service department at 800-334-3646 for a returned goods authorization, return instruction and credit. The accounts were also requested to notify their customers of the recall, and to complete and return the enclosed reply form. For questions regarding this recall call 815-385-0100.
Quantity in Commerce 240 cases
Distribution Nationwide Distribution including California, Indiana, New York and Texas
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = LYZ and Original Applicant = QINGDAO LANG HUI IMPORT & EXPORT CO., LTD
-
-