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FDAFDA · Food and drugs·Recall number Z-1025-2013

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.

Published April 10, 2013 · Recall initiated: August 22, 2012

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Viscot Medical LLC
Distributor
USA Nationwide Distribution
Lot
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 #).
Risk classification
Class III
Area (FDA)
device
Country
United States

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