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U.S. Department of Health and Human Services

Class 3 Device Recall Stic Kit Needle Containment Device

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  Class 3 Device Recall Stic Kit Needle Containment Device see related information
Date Initiated by Firm April 03, 2006
Date Posted October 20, 2006
Recall Status1 Terminated 3 on February 21, 2007
Recall Number Z-0056-2007
Recall Event ID 36165
510(K)Number K900035  
Product Classification Stic Kit Needle Containment Device - Product Code MMK
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.
Code Information The recalled units are identified with the Lot Codes: 070505 and 110602.
Recalling Firm/
Manufacturer
EM Innovations Inc
6106 Bausch Rd
Galloway OH 43119-9382
For Additional Information Contact
614-853-1504
Manufacturer 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 Determined
Cause 2
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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MMK and Original Applicant = WILSON-COOK MEDICAL, INC.
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