Device 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.
Z-0137-2014
Product summary
- Firm
- ITC-Nexus Dx
- Event
- Event 66353
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6 boxes (Each box contains 50 Surgicutt Devices plus 55 sheets of Blotting Paper).
- Official record key
device-enforcement:Z-0137-2014
Official wording
Reason: ITC has determined that the blade in their Surgicutt with Blotting Paper (Product Code: SUB50I; Lot: AK301M) devices may be loose.
Code information: Product Code: SUB50I; Lot No. AK301M. Lot Expiration Date 8/31/2017
Distribution pattern: Nationwide Distribution including Arizona andTexas. .
Derived failure modes
-
Unknown
ITC has determined that the blade in their Surgicutt with Blotting Paper (Product Code: SUB50I; Lot: AK301M) devices may be loose.