Stryker, REF: 0250070450, 5.0 mm x 45 cm, Strykeprobe, Outer Sheath Replacement, RX Only, Non-Sterile, CE, UDI: (01) 07613327051926 This products was distributed with the following sheath/probe: 0250070451-PKG, 5MM X 45CM StrykeProbe Electrosurgical Probe, Spatula-Tip, 0250070452-PKG, 5MM X 45CM StrykeProbe Electrosurgical Probe, J-TIP, 0250070453-PKG, 5MM X 45CM StrykeProbe Electrosurgical Probe, L-TIP, 0250070455-PKG, 5MM X 45CM StrykeProbe Electrosurgical Probe, Needle Tip

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Lot Numbers: 010818-02, 010818-05, 010818-06, 010818-07, 010818-08, 010818-09, 040816-01, 040816-02
  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:
Stryker Corporation
Reason for Recall:
Potential diff. in the length of the sheath tube and the sheath/probe. A diff. in length could lead to the base of the sheath/probe not being fully seated in the sheath tube which could result in the distal tip of the sheath melting. This could lead to a compromised insulation, leading to unintentional flow of electricity to the patient. The sheath/probe is packaged separately.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Stryker, REF: 0250070450, 5.0 mm x 45 cm, Strykeprobe, Outer Sheath Replacement, RX Only, Non-Sterile, CE, UDI: (01) 07613327051926 This products was distributed with the following sheath/probe: 0250070451-PKG, 5MM X 45CM StrykeProbe Electrosurgical Probe, Spatula-Tip, 0250070452-PKG, 5MM X 45CM StrykeProbe Electrosurgical Probe, J-TIP, 0250070453-PKG, 5MM X 45CM StrykeProbe Electrosurgical Probe, L-TIP, 0250070455-PKG, 5MM X 45CM StrykeProbe Electrosurgical Probe, Needle Tip

Product Codes/Lot Numbers:

Lot Numbers: 010818-02, 010818-05, 010818-06, 010818-07, 010818-08, 010818-09, 040816-01, 040816-02

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1509-2020

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