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.
Recall
- Recall Number
- Z-0137-2014
- Event Number
- 66353
- Firm
- ITC-Nexus Dx
- FEI Number
- 2250033
- Product Code
- JCA
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- August 22, 2013
- Terminated
- June 9, 2014
- Address
- 23 Nevsky St, Edison, NJ, 08820-2425
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.
ITC has determined that the blade in their Surgicutt with Blotting Paper (Product Code: SUB50I; Lot: AK301M) devices may be loose.
ITC sent a Medical Device Recall letter dated September 20, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to remove/quarantine affected product in their inventory and to return the affected product to ITC. Customers with questions were instructed to call 1-800-631-5945. Questions regarding this recall call 732-548-7000, ext 4476.
Nationwide Distribution including Arizona andTexas. .
6 boxes (Each box contains 50 Surgicutt Devices plus 55 sheets of Blotting Paper).