BEUDAMED
    FDA Recall Terminated

    LigaSure Blunt Tip Laparoscopic Sealer/Divider, Nano-Coated, Product Number LF1837

    Recall: Z-0495-2022 · Initiated December 6, 2021

    Recall

    Recall Number
    Z-0495-2022
    Event Number
    89182
    Firm
    Covidien Llc
    FEI Number
    1282497
    Product Code
    GEI
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    December 6, 2021
    Posted
    January 13, 2022
    Terminated
    May 11, 2023
    Address
    15 Hampshire St, Mansfield, MA, 02048-1113

    Description

    LigaSure Blunt Tip Laparoscopic Sealer/Divider, Nano-Coated, Product Number LF1837

    Reason

    Customers reported that the device jaws were difficult to open or would not open following application on tissue. Use of a device with this potential assembly issue could result in the potential for bleeding, unintended tissue injury or loss, and delay in treatment while an alternate device is obtained.

    Action

    URGENT MEDICAL DEVICE RECALL notification letters dated 12/2021 were sent to customers. Customer Action Required: 1. Please immediately quarantine and discontinue use of the affected item code with the associated lot number listed above. 2. Please return affected product as indicated below. All products from the affected item code and associated lot number must be returned. 3. If you have distributed the product item code and lot number listed above, please promptly forward the information from this letter to those recipients. 4. Complete the Recalled Product Return Form even if you do not have inventory and email it to [email protected] We regret any inconvenience this may cause. We are committed to patient safety and appreciate your prompt attention to this matter. If you have any questions regarding this communication, please do not hesitate to contact Azi Hosseini on +61 428 464 838, or [email protected]

    Distribution

    Worldwide Distribution in the countries of Australia, Austria, Belgium, Czech Republic, France, Germany, Ireland, Kazakhstan, Netherlands, Spain, United Kingdom. No US distribution.

    Quantity

    504 devices