BEUDAMED
    FDA Enforcement Class II Ongoing

    Regard ¿ custom surgical pack labeled as "LAPAROSCOPIC - OSU" including recalled Stryker part numbers 0620 040 660 Pneumosure High Flow II Tubeset, 0620 040 690 Pneumosure Heated Tubeset with RTP and 0620 040 680 Pneumosure High Flow Tubeset with RTP.

    Recall: Z-2221-2019 · Reported August 14, 2019

    Enforcement

    Recall Number
    Z-2221-2019
    Event ID
    82499
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    ROi Consolidated Service Center (CSC)
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    August 14, 2019
    Initiation Date
    March 21, 2019
    Classification Date
    August 8, 2019
    Address
    2909 N Neergard Ave, N/A, Springfield, MO, 65803-6317, United States

    Description

    Regard ¿ custom surgical pack labeled as "LAPAROSCOPIC - OSU" including recalled Stryker part numbers 0620 040 660 Pneumosure High Flow II Tubeset, 0620 040 690 Pneumosure Heated Tubeset with RTP and 0620 040 680 Pneumosure High Flow Tubeset with RTP.

    Reason

    Resource Optimization & Innovation (ROi) has received a recall notice from Stryker regarding tube sets potentially detaching from the cassette, which can lead to leaking gas or a hissing sound.

    Code Info

    Item Number (Lot Number, Expiration Date): 880341004 (043444D, 43566); 880341005 (047474E, 43706); 880341005 (049043E, 43750);

    Distribution

    Distributed to LA and MO

    Quantity

    312 packs