Device 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.
Z-1025-2013
Product summary
- Event
- Event 64075
- Status
- Terminated
- Classification
- Class III
- Quantity
- 458,589 markers
- Official record key
device-enforcement:Z-1025-2013
Official wording
Reason: Dual Tip Marker has inconsistent ink flow on the black permanent ink side.
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 #).
Distribution pattern: USA Nationwide Distribution
Derived failure modes
-
Unknown
Dual Tip Marker has inconsistent ink flow on the black permanent ink side.