🔍 RecallPedia

Fixed Core Wire Guide, RPN TSCF-35-260-3, GPN G00517. The product is a curved wire guide with PTFE coating manufactured from stainless steel. To assist in inserting catheters, introducer sheaths, and other medical devices in vascular applications.

Class I - Dangerous
🏥 Medical Devices Recalled: October 22, 2020 Cook Surgical Instruments

What Should You Do?

  1. Check if you have this product:
    Lot 13199931 with UDI (01)00827002005174(17)250824(10)13199931
  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:
Cook Inc.
Reason for Recall:
Affected product was dropped during manufacturing, which may result in a bent wire guide and/or the presence of loose foreign matter on the wire guide.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Fixed Core Wire Guide, RPN TSCF-35-260-3, GPN G00517. The product is a curved wire guide with PTFE coating manufactured from stainless steel. To assist in inserting catheters, introducer sheaths, and other medical devices in vascular applications.

Product Codes/Lot Numbers:

Lot 13199931 with UDI (01)00827002005174(17)250824(10)13199931

Distribution:

Distributed in: US, AZ, IA, IN, MA, ND

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0399-2021

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