Model EMI 82691, Stic Kit Needle Containment Device. These devices are packaged 60 per case. Stick-on label on device an
FDA device recall Z-0056-2007 · posted 2006-10-20 · Terminated
Recall details
- Recalling firm
- EM Innovations Inc
- Reason for recall
- The firm failed to include User Instructions with the Stic Kit Needle Containment Device, Model EMI 82691, which they shipped to distributor/customers.
- Action taken
- 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, at which time, it was determined that that all of the distributors either had old User Instructions in stock for distribution, or that there were no affected device units left in inventory.
- Root cause
- Other
- Status
- Terminated
- Product code
- MMK
- Quantity affected
- 2,462 units
- Distribution
- The recalled device was shipped to distributor/customers located in the following states: MO, OH, WI, PA and NJ.
- Date initiated
- 2006-04-03
- Date posted
- 2006-10-20
- Date terminated
- 2007-02-21
- Location
- Galloway, OH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| WILSON-COOK COLON DECOMPRESSION SET (K900035) | Wilson-Cook Medical, Inc. | 1990-03-07 |