Recall Z-1553-2011 ยท OIG Powder-Free Guayle Rubber Examination Glove
Medline Industries Inc
Medline Industries, Inc. "Cedar" brand Vinyl Economy Exam Glove, Powder-Free, Medium Size, Catalog Number: MSV402P, Lot Number: JCU04958569
| Date | Mar 4, 2011 (initiated Feb 3, 2011) |
| Status | Terminated |
| Reason | The recall was initiated because the affected lot, lot number JCU004958569, of gloves did not meet the requirements for the water-leak test. |
| Root cause | Release of Material/Component prior to receiving test results |
| Action | MEDLINE INDUSTRIES, INC. sent a RECALL NOTICE IMMEDIATE ACTION REQUIRED letter by US Mail on February 10, 2011, to all affected cusomters. The letter identified the product, the problem, and the action to be taken by the customer. The customers were instructed to: 1. Immediately quarantine ALL inventory of the affected lot for return to Medline. 2. Complete the attached recall verification form. Please complete this form EVEN IF you have none of the affected lot in stock. 3. Fax or email the completed form to Medline. The email address is Recalls@Medline.com or faxed the form to 866-7 |
| Quantity | 2,100 cases (2,100,000 units) |
| Distribution | Nationwide Distribution including CA, HI, and NV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081655 | POWDER FREE VINYL PATIENT EXAMINATION GLOVES (LIGHT YELLOW) Jiangsu Cureguard Glove Co., Ltd., Jul 21, 2008 |