Recall Z-0712-2012 ยท LYY Latex Patient Examination Glove
Adenna Inc
Phantom-brand Black Latex Powder Free Examination Gloves, 100 gloves by weight, size small and Medium, Product Code PHM912, Lot No. 002-E1LF302-1, Manufacture date JUL 2011, Size Small Product Code PHM915, Lot No. 002-E1LF305-1, Manufacture date JUL 2011, Size Medium Examination Disposable Gloves
| Date | Jan 11, 2012 (initiated Dec 22, 2011) |
| Status | Terminated |
| Reason | The recall was initiated because Adenna Inc. distributed latex gloves that have been FDA refused. |
| Root cause | Release of Material/Component prior to receiving test results |
| Action | Adenna Inc. sent a recall letter dated December 22, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to examine their inventory and quarantine the products that are subject to the recall. Customers were instructed to notify their customers if they have further distributed the products. Customers were instructed to cease using the recalled products, and Adenna will replace the products. Customers were instructed to complete and return the enclosed response form as soon as possible. |
| Quantity | 427 cartons |
| Distribution | Nationwide Distribution including the states of: FL, CA, NY, NV, NC, MD, TX, OR, AZ, OH, MN, and IL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K100694 | COLORED POWDER FREE AND POLYMER COATED EXAMINATION GLOVE (BLUE, BLACK AND PINK) WITH A PROTEIN CLAIM OF LESS THAN Tekmedic (M) Sdn Bhd, Jun 25, 2010 |