| Class 3 Device Recall Dual Tip Marker | |
Date Initiated by Firm | August 22, 2012 |
Date Posted | March 29, 2013 |
Recall Status1 |
Terminated 3 on July 21, 2014 |
Recall Number | Z-1025-2013 |
Recall Event ID |
64075 |
Product Classification |
Marker, skin - Product Code FZZ
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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 NJ 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 | 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 |
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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.
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