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Terminated

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.

FDA Recall Z-1025-2013 · Posted 2013-03-29

Recalling FirmViscot Medical LLC
Recall StatusTerminated
Product CodeFZZ
Date Initiated2012-08-22
Date Terminated2014-07-21
Product Quantity458,589 markers

Reason for Recall

Dual Tip Marker has inconsistent ink flow on the black permanent ink side.

Firm 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.

Root Cause

Device Design

Distribution Pattern

USA Nationwide Distribution

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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