Recall Z-0137-2014 ยท JCA Device, Bleeding Time
ITC-Nexus Dx
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 determ
| Date | Aug 22, 2013 |
| Status | Terminated |
| Reason | ITC has determined that the blade in their Surgicutt with Blotting Paper (Product Code: SUB50I; Lot: AK301M) devices may be loose. |
| Root cause | Nonconforming Material/Component |
| Action | 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. |
| Quantity | 6 boxes (Each box contains 50 Surgicutt Devices plus 55 sheets of Blotting Paper). |
| Distribution | Nationwide Distribution including Arizona andTexas. . |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.