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.
FDA Recall Z-0056-2007 · Posted 2006-10-20
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Recalling FirmEM Innovations Inc
Recall StatusTerminated
Product CodeMMK
Date Initiated2006-04-03
Date Terminated2007-02-21
Product Quantity2,462 units
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.
Firm 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, 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
Distribution Pattern
The recalled device was shipped to distributor/customers located in the following states: MO, OH, WI, PA and NJ.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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