Recall Z-0056-2007 ยท MMK Container, Sharps
EM Innovations Inc
Model EMI 82691, Stic Kit Needle Containment Device. These devices are packaged 60 per case. Stick-on label on device and User Instruction sheet are attached to the case with a rubber band.
| Date | Oct 20, 2006 (initiated Apr 3, 2006) |
| Status | Terminated |
| Reason | The firm failed to include User Instructions with the Stic Kit Needle Containment Device, Model EMI 82691, which they shipped to distributor/customers. |
| Root cause | Other |
| Action | The recalling firm contacted all fifteen (15) of its distributor/customers (not just the distributors that received the affected devices) via telephone on 4/3-5/2006 in order to inform them that the User Instructions had not been included with the needle containment devices that were shipped between 7/5/2005 and 4/3/2006. The firm asked that the distributors check their inventories and if it was determined that User Instructions were missing, report the amount needed to the recalling firm which would in turn send them out. The firm followed up on their recall action via telephone on 7/11/2006, |
| Quantity | 2,462 units |
| Distribution | The recalled device was shipped to distributor/customers located in the following states: MO, OH, WI, PA and NJ. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K900035 | WILSON-COOK COLON DECOMPRESSION SET Wilson-Cook Medical, Inc., Mar 7, 1990 |