The Recall Desk

FDA (Devices) recall action 85100

Stryker Corporation recalled 2 products on 2020-03-25

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2020-03-25
Critical
0
Units
525

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • HighFDA (Devices)··2020-03-25

    Stryker Strykeprobe Outer Sheath Replacement Recalled for Insulation Risk

    Stryker is recalling Strykeprobe Outer Sheath Replacements because a length mismatch could cause the probe to melt, compromising insulation and allowing electricity to flow to the patient.

    Product
    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, 02500
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2020-03-25

    Stryker Strykeprobe Outer Sheath Recalled for Potential Electrical Hazard

    Stryker is recalling 525 Strykeprobe Outer Sheath Replacement devices due to a potential length mismatch that could cause sheath melting and unintended electrical flow to patients.

    Product
    Stryker, REF: 0250070460, 5.0 mm x 32 cm, Strykeprobe, Outer Sheath Replacement, RX Only, Non-Sterile, CE, UDI: (01) 07613327051971 These products are distributed with the following sheath/probe: 0250070441-PKG, StrykeFlow Electrocautery Probe, Spatula Tip 5MM 0250070442-PK
    Category
    Distribution
    0 states