BEUDAMED
    FDA Recall Terminated

    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-PKG, StrykeFlow Electrocautery Probe, J Tip, 5MM 0250070443-PKG, StrykeFlow Electrocautery Probe, L Tip, 5MM 0250070444-PKG, StrykeFlow Electrocautery Probe, Ball Tip, 5MM 0250070445-PKG, StrykeFlow Electrocautery Probe, Needle Tip 5MM 0250070446-PKG, StrykeFlow Electrocautery Probe, Spoon Tip, 5MM

    Recall: Z-1508-2020 · Initiated September 12, 2019

    Recall

    Recall Number
    Z-1508-2020
    Event Number
    85100
    Firm
    Stryker Corporation
    FEI Number
    2936485
    Product Code
    GEI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 12, 2019
    Terminated
    October 31, 2022
    Address
    5900 Optical Ct, San Jose, CA, 95138-1400

    Description

    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-PKG, StrykeFlow Electrocautery Probe, J Tip, 5MM 0250070443-PKG, StrykeFlow Electrocautery Probe, L Tip, 5MM 0250070444-PKG, StrykeFlow Electrocautery Probe, Ball Tip, 5MM 0250070445-PKG, StrykeFlow Electrocautery Probe, Needle Tip 5MM 0250070446-PKG, StrykeFlow Electrocautery Probe, Spoon Tip, 5MM

    Reason

    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.

    Action

    On September 25, 2019 and November 26, 2019, the firm sent an "Urgent Medical Device Recall Notification" letter to all consignees via USPS mail. In addition, to informing consignees about the recall, they recall letter asked consignees to take the following actions: Actions to be taken by the Customer/User: 1. Inform individuals within your organization who need to be aware of this device removal. 2. Check all stock areas and/or operating room storage to determine if any devices with the affected Strykeprobe Sheath lot numbers from Attachment A are at your facility. - a. If you would like a list of all affected probe lot numbers, please email [email protected] 3. If affected product is found, segregate the product and call Stryker customer service at 1-800-624-4422 (Option 3) or email [email protected] to arrange for product return and issuance of credit or replacement (upon availability). - a. Remove the affected sheath, quarantine, and discontinue use of the identified non-conforming recalled sheath(s). - b. When returning units, please enclose Business Reply Form on Attachment B. 4. If affected product is NOT found: - a. Please complete Business Reply Form on Attachment B and return to [email protected] 5. Please forward a copy of this letter to any other personnel within your facility you deem appropriate. 6. Please send any questions to [email protected].

    Distribution

    OUS: Netherlands, Spain, Switzerland, Colombia, Canada, Japan, Taiwan,, Puerto Rico, South Africa, and South Korea

    Quantity

    525 devices