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.
FDA Recall Z-0137-2014 · Posted None
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Recalling FirmITC-Nexus Dx
Recall StatusTerminated
Product CodeJCA
Date Initiated2013-08-22
Date Terminated2014-06-09
Product Quantity6 boxes (Each box contains 50 Surgicutt Devices plus 55 sheets of Blotting Paper).
Reason for Recall
ITC has determined that the blade in their Surgicutt with Blotting Paper (Product Code: SUB50I; Lot: AK301M) devices may be loose.
Firm 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Nationwide Distribution including Arizona andTexas. .
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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