Recall Z-1025-2013— Viscot Medical LLC
Class III · Terminated
Class III FDA medical device recall by Viscot Medical LLC, initiated 2012-08-22, terminated 2014-07-21. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Dual Tip Marker has inconsistent ink flow on the black permanent ink side..
- Recalling firm
- Viscot Medical LLC
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2012-08-22
- Terminated
- 2014-07-21
- Firm location
- East Hanover, NJ, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.