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U.S. Department of Health and Human Services

Class 2 Device Recall General Pack contains Devon Light Glove

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  Class 2 Device Recall General Pack contains Devon Light Glove see related information
Date Initiated by Firm April 20, 2015
Date Posted July 07, 2015
Recall Status1 Completed
Recall Number Z-2002-2015
Recall Event ID 71130
Product Classification General surgery tray (kit) - Product Code LRO
Product General Pack - contains Devon Light Glove
Used during surgery
Code Information Pack 670-115
Recalling Firm/
Manufacturer
Stradis Healthcare, LLC.
805 Marathon Pkwy Ste 100
Lawrenceville GA 30046-2885
For Additional Information Contact Susan Brandvold
770-962-2425 Ext. 213
Manufacturer Reason
for Recall
Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.
FDA Determined
Cause 2
Nonconforming Material/Component
Action Medtronic sent an Urgent Medical Device Recall letter dated April 16, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to quarantine and discontinue use of the affected device. Complete the Recalled Product Return Form and fax to 800-895-6140 or email to feedback.customerservice@Covidien.com. Customers with questions regarding return of the product should call 1-727-642--4124.
Quantity in Commerce One
Distribution Distribution US nationwide to AL, AK, CA, DE, FL, GA, HI, ID, IL, IN, KS, KY, ME, MD, MA, MI, MS, MO, NM, NJ, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA; Canada and Dubai

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.
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