Recall Z-0137-2014— ITC-Nexus Dx
Class II · Terminated
Class II FDA medical device recall by ITC-Nexus Dx, initiated 2013-08-22, terminated 2014-06-09. FDA's recall record names no specific 510(k) clearance for this event. Product: Surgicutt fully automated incision making device for bleeding time determination. ITC 8 Olsen Avenue, Edison, NJ 08820. 732.548.5700. www.itcmed.com. A subsidiary of Thoratec Corporation. The device is a spring loaded cam driven device that provides standardized incisions of 5 mm length and 1 mm depth. This fully automated instrument is used along with blotting paper for bleeding time determinations.. Reason: ITC has determined that the blade in their Surgicutt with Blotting Paper (Product Code: SUB50I; Lot: AK301M) devices may be loose..
- Recalling firm
- ITC-Nexus Dx
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-08-22
- Terminated
- 2014-06-09
- Firm location
- Edison, NJ, United States
Product description
Surgicutt fully automated incision making device for bleeding time determination. ITC 8 Olsen Avenue, Edison, NJ 08820. 732.548.5700. www.itcmed.com. A subsidiary of Thoratec Corporation. The device is a spring loaded cam driven device that provides standardized incisions of 5 mm length and 1 mm depth. This fully automated instrument is used along with blotting paper for bleeding time determinations.
Reason for recall
ITC has determined that the blade in their Surgicutt with Blotting Paper (Product Code: SUB50I; Lot: AK301M) devices may be loose.
Data sourced from openFDA. This site is unofficial and independent of the FDA.