Date Initiated by Firm | November 15, 2011 |
Date Posted | January 11, 2012 |
Recall Status1 |
Terminated 3 on October 08, 2012 |
Recall Number | Z-0679-2012 |
Recall Event ID |
60552 |
510(K)Number | K093264 |
Product Classification |
Vinyl patient examination glove - Product Code LYZ
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Product | Zee Clear Vinyl Medical Examination Gloves, Powder Free, Medium, Non-Sterile; 100 gloves per box, 10 boxes per case; Distributed by Zee Medical, Inc., Irvine, CA 92606, Made in China; Zee Part No.: 3061
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.: 3061, lot number CZA04-22 |
Recalling Firm/ Manufacturer |
Cypress Medical Products LLC 1202 S Il Route 31 Mchenry IL 60050
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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 | 280 cases |
Distribution | Nationwide Distribution including California, Indiana, New York and Texas |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = LYZ
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