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U.S. Department of Health and Human Services

Class 3 Device Recall Dual Tip Marker

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 Class 3 Recall
Dual Tip Marker
see related information
Date Posted March 29, 2013
Recall Status1 Open
Recall Number Z-1025-2013
Recall Event ID 64075
Product Classification Marker, Skin - Product Code FZZ
Product Dual Tip Marker, Sterile Product Usage: A writing instrument intended to mark paper and plastic items around the sterile field during surgery. It has two tips. One is black for miscellaneous use. The other is for surgical skin marking.
Code Information Lot# 022043, 022045, 022046, 042084, 042085, 042086, 042087, 042088, 042089, 052128, 052129, 052130, 052131, 062167, 062168, 062169, 062170, 072200, 072201, 072203, 072205, 072206, 072207 (Including any letter suffixes after lot #).
Recalling Firm/
Manufacturer
Viscot Medical LLC
32 West St
East Hanover, New Jersey 07936-2822
For Additional Information Contact Mr. Gary Pieringer
973-887-9273
Manufacturer Reason
for Recall
Dual Tip Marker has inconsistent ink flow on the black permanent ink side.
FDA Determined
Cause 2
DESIGN: Device Design
Action Viscot Medical LLC sent a Customer Notification Letter dated August 22, 2012 to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to return the affected product for a replacement. To return the product call 1-800-221-0658 or e-mail jeffl@viscot .com for the RGA.
Quantity in Commerce 458,589 markers
Distribution USA Nationwide Distribution
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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