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
Recall
- Recall Number
- Z-0680-2012
- Event Number
- 60552
- Firm
- Cypress Medical Products LLC
- FEI Number
- 1451040
- Product Code
- LYZ
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- November 15, 2011
- Posted
- January 11, 2012
- Terminated
- October 8, 2012
- Address
- 1202 S Il Route 31, Mchenry, IL, 60050
Description
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
The gloves fail to meet the performance requirements of 21 CFR 800.20 for leakage defects.
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.
Nationwide Distribution including California, Indiana, New York and Texas
240 cases