FDAFDA · Food and drugs·Recall number Z-0137-2014
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.
Published November 13, 2013 · Recall initiated: August 22, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
ITC has determined that the blade in their Surgicutt with Blotting Paper (Product Code: SUB50I; Lot: AK301M) devices may be loose.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- ITC-Nexus Dx
- Distributor
- Nationwide Distribution including Arizona andTexas. .
- Lot
- Product Code: SUB50I; Lot No. AK301M. Lot Expiration Date 8/31/2017
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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