Z-0056-2007

Model EMI 82691, Stic Kit Needle Containment Device. These devices are packaged 60 per case. Stick-on label...

Name: Z-0056-2007 Model EMI 82691, Stic Kit Needle Containment Device. These devices are packaged 60 per case. Stick-on label...
Creator: EM Innovations Inc
Published: 2006-04-03
License: https://open.fda.gov/license/

EM Innovations Inc / initiated 2006-04-03 / Terminated

FDA source

EM Innovations Inc began a recall of 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... on 2006-04-03. The reason FDA records is "The firm failed to include User Instructions with the Stic Kit Needle Containment Device, Model EMI 82691, which they shipped to distributor/customers". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0056-2007
Status: Terminated
Initiated: 2006-04-03
Posted: 2006-10-20
Terminated: 2007-02-21
Recalling firm: EM Innovations Inc
Product: 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.
Product code: MMK Container, Sharps
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.
FDA 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, 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.
Quantity in commerce: 2,462 units
Distribution: The recalled device was shipped to distributor/customers located in the following states: MO, OH, WI, PA and NJ.
Product codes and lots: The recalled units are identified with the Lot Codes: 070505 and 110602.

Product code MMK

K900035Class IIWilson-Cook Colon Decompression SetWilson-Cook Medical, Inc. / cleared 1990-03-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)