Z-1025-2013 Class III Terminated
FDA device recall Z-1025-2013 was initiated by Viscot Medical LLC on August 22, 2012 and is designated Class III. Reason for recall: Dual Tip Marker has inconsistent ink flow on the black permanent ink side. The recall status is terminated (terminated July 21, 2014). Affected quantity: 458,589 markers.
Recall Details
- Product Type
- Devices
- Report Date
- April 10, 2013
- Initiation Date
- August 22, 2012
- Termination Date
- July 21, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 458,589 markers
Product Description
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.
Reason for Recall
Dual Tip Marker has inconsistent ink flow on the black permanent ink side.
Distribution Pattern
USA Nationwide Distribution
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 #).