🔍 RecallPedia

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.

Class I - Dangerous
🏥 Medical Devices Recalled: August 22, 2013 ITC-Nexus Dx Surgical Instruments Nationwide

What Should You Do?

  1. Check if you have this product:
    Product Code: SUB50I; Lot No. AK301M. Lot Expiration Date 8/31/2017
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
ITC-Nexus Dx
Reason for Recall:
ITC has determined that the blade in their Surgicutt with Blotting Paper (Product Code: SUB50I; Lot: AK301M) devices may be loose.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

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.

Product Codes/Lot Numbers:

Product Code: SUB50I; Lot No. AK301M. Lot Expiration Date 8/31/2017

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0137-2014

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ITC-Nexus Dx

Class I - Dangerous

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