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.
This recall has been terminated (originally issued October 20, 2006).
- Company
- Em Innovations Inc
- Recall Initiated
- April 3, 2006
- Posted
- October 20, 2006
- Terminated
- February 21, 2007
- Recall Number
- Z-0056-2007
- Quantity
- 2,462 units
- Firm Location
- Galloway, OH
- Official Source
- View on FDA website ↗
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.
Distribution
The recalled device was shipped to distributor/customers located in the following states: MO, OH, WI, PA and NJ.
Lot / Code Info
The recalled units are identified with the Lot Codes: 070505 and 110602.
Root Cause
Other
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.