Reported Nov 13, 2013 · Terminated
Surgicutt fully automated incision making device for bleeding time determination. ITC 8 Olsen Avenue, Edison, NJ 08820.…
ITC-Nexus Dx
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: ITC-Nexus Dx · 23 Nevsky St · Edison, NJ · 08820-2425
Is this the product you have?
- 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.
- Lot codes and dates
- Product CodeSUB50I; Lot No. AK301M. Lot Expiration Date 8/31/2017
- Amount recalled
- 6 boxes (Each box contains 50 Surgicutt Devices plus 55 sheets of Blotting Paper).
Where it was sold
- Nationwide
- AZ
Why it was recalled
ITC has determined that the blade in their Surgicutt with Blotting Paper (Product Code: SUB50I; Lot: AK301M) devices may be loose.
This product could cause temporary or reversible health problems — stop using it.
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