Recall Z-0679-2012 ยท LYZ Vinyl Patient Examination Glove
Cypress Medical Products LLC
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
| Date | Jan 11, 2012 (initiated Nov 15, 2011) |
| Status | Terminated |
| Reason | The gloves fail to meet the performance requirements of 21 CFR 800.20 for leakage defects. |
| Root cause | 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 requ |
| Quantity | 280 cases |
| Distribution | Nationwide Distribution including California, Indiana, New York and Texas |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K093264 | VINYL EXAMINATION GLOVE, POWDER FREE, NON-COLORED Qingdao Lang Hui Import & Export Co., Ltd., May 28, 2010 |