Reported Mar 25, 2020 · Terminated
Stryker, REF: 0250070450, 5.0 mm x 45 cm, Strykeprobe, Outer Sheath Replacement, RX Only, Non-Sterile, CE, UDI: (01)…
Stryker Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Stryker Corporation · 5900 Optical Ct · San Jose, CA · 95138-1400
Is this the product you have?
- Stryker
- REF0250070450, 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-PKG5MM X 45CM StrykeProbe Electrosurgical ProbeSpatula-Tip0250070452-PKG5MM X 45CM StrykeProbe Electrosurgical ProbeJ-TIP0250070453-PKG5MM X 45CM StrykeProbe Electrosurgical ProbeL-TIP0250070455-PKG5MM X 45CM StrykeProbe Electrosurgical ProbeNeedle Tip
- Lot codes and dates
- Lot Numbers
010818-02010818-05010818-06010818-07010818-08010818-09040816-01040816-02
- Lot Numbers
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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