Recall Z-1025-2013
Viscot Medical LLC · initiated August 22, 2012
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
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.
Codes / lots: 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 #).
Reason for recall
Dual Tip Marker has inconsistent ink flow on the black permanent ink side.
FDA-determined cause: Device Design
Action taken
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.
Details
- Recall number
- Z-1025-2013
- Initiated
- August 22, 2012
- Posted by FDA
- March 29, 2013
- Terminated
- July 21, 2014
- Product code
- FZZ – Marker, Skin
- Quantity
- 458,589 markers
- Distribution
- USA Nationwide Distribution
- Recalling firm
- Viscot Medical LLC, East Hanover, NJ