BEUDAMED
    FDA Enforcement Class II Ongoing

    FLEX. BIOPSY FORCEPS 5FR WL 550MM, Product Number 829.051

    Recall: Z-1423-2023 · Reported May 3, 2023

    Enforcement

    Recall Number
    Z-1423-2023
    Event ID
    91953
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Richard Wolf GmbH
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 3, 2023
    Initiation Date
    March 24, 2023
    Classification Date
    April 24, 2023
    Address
    Pforzheimer Str. 32, N/A, Knittlingen, N/A, N/A, Germany

    Description

    FLEX. BIOPSY FORCEPS 5FR WL 550MM, Product Number 829.051

    Reason

    Potentially unable to open forceps jaws when the endoscope shaft is bent by about 90 degrees. If, in addition, the proximal forceps shaft is bent, the forceps can no longer be opened or restrictions begin even with a slight bending of the endoscope.

    Code Info

    UDI/DI: 04055207009635; Lot Numbers: 4500377840, 4500377840, 4500377840, 4500376297, 4500371970, 4500363663, 4500363098, 4500361404, 4500353562, 4500349168, 4500347747, 4500338560, 4500333999

    Distribution

    Worldwide distribution - US Nationwide and the countries of United Arab Emirates (AE), Argentina (AR), Austria (AT), Belgium (BE), BO, Brazil (BR), Canada (CA), Chile (CL), Czech Republic (CZ), Germany (DE), Denmark (DK), Ecuador (EC), Spain (ES), Finland (FI), France (FR), Greece (GR), Hong Kong (HK), Croatia (HR), Ireland (IE), India (IN), Italy (IT), Jordan (JO), Japan (JP), South Korea (KR), Kuwait (KW), Kazakhstan (KZ), LB, Lithuania (LT), Marzocco (MA), Mexico (MX), Netherlands (NL), Norway (NO), New Zealand (NZ), Oman (OM), Pakistan (PK), Poland (PL), Palestine (PS), Portugal (PT), Qatar (QA), Romania (RO), Serbia (RS), Russian Federation (RU), Saudi Arabia (SA), Slovenia (SI), Slovakia (SK), Thailand (TH), Turkey (TR).

    Quantity

    342 units