Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall 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

U.S. FDA — Device Enforcement · United States · 2013-08-22 · Class II

AI-assisted, human-edited — this page is drafted with AI from public-source data, then reviewed before publication. How we use AI →

Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0137-2014
Date of alert: 2013-08-22
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: ITC-Nexus Dx
Product category: device
Product type: Devices

Reported risk: ITC has determined that the blade in their Surgicutt with Blotting Paper (Product Code: SUB50I; Lot: AK301M) devices may be loose.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

Related