BEUDAMED
    FDA Enforcement Class II Ongoing

    SPROTTE Lumbar with Introducer, labeled as the following: 1. Sprotte 22G x 90mm w/ introducer and wings (25/box); 2. Sprotte 22G x 120mm w/ introducer and wings (25/box); 3. Sprotte 19G x 90mm w/ introducer and wings (25/box]); 4. Sprotte 22G x 103mm w/ introducer and wings (25/box); 5. Sprotte 21G x 90mm w/ introducer and wings (25/box); 6. Sprotte 21G x 103mm w/ introducer and wings (25/box); 7. Sprotte 20G x 103mm w/ introducer and wings (25/box); 8. Sprotte 20G x 90mm w/ introducer and wings (25/box) Product Usage: The SPROTTE¿ lumbar puncture needles are intended to gain entry into or puncture the spinal cavity permitting injection (including anesthesia) / withdrawal of fluids for purposes of diagnostic lumbar puncture, myelography/ discography procedures. The device is intended for adult and pediatric patients.

    Recall: Z-0234-2020 · Reported November 6, 2019

    Enforcement

    Recall Number
    Z-0234-2020
    Event ID
    83714
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Pajunk GmbH
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    November 6, 2019
    Initiation Date
    August 30, 2019
    Classification Date
    October 29, 2019
    Address
    Karl-hall-str. 1, Geisingen, N/A, Germany

    Description

    SPROTTE Lumbar with Introducer, labeled as the following: 1. Sprotte 22G x 90mm w/ introducer and wings (25/box); 2. Sprotte 22G x 120mm w/ introducer and wings (25/box); 3. Sprotte 19G x 90mm w/ introducer and wings (25/box]); 4. Sprotte 22G x 103mm w/ introducer and wings (25/box); 5. Sprotte 21G x 90mm w/ introducer and wings (25/box); 6. Sprotte 21G x 103mm w/ introducer and wings (25/box); 7. Sprotte 20G x 103mm w/ introducer and wings (25/box); 8. Sprotte 20G x 90mm w/ introducer and wings (25/box) Product Usage: The SPROTTE¿ lumbar puncture needles are intended to gain entry into or puncture the spinal cavity permitting injection (including anesthesia) / withdrawal of fluids for purposes of diagnostic lumbar puncture, myelography/ discography procedures. The device is intended for adult and pediatric patients.

    Reason

    Problem with packaging sealing process which affects sterility.

    Code Info

    Lot Numbers 1240 through 1313. Item numbers: 1. 321151-30C; 2. 331151-30C; 3. 321151-31C; 4. 341151-30C; 5. 321151-31A; 6. 341151-31A; 7. 341151-31B; 8. 331151-31B

    Distribution

    Worldwide distributions - US Nationwide including the states of AR, AZ, CA, CO, CT, DC, FL, GA, IL, IN, LA, MA, MD, MI, MN, MO, NC, NJ, NY, OH, RI, SC, TN, TX, WI, WY. Countries of Germany, Ellada / Greece, Canada, Italy, Lietuva / Lithuania/ Litauen, Australia, Luxembourg, Austria, Nederland / Netherlands, Belgium, Polska / Poland, Switzerland, Sverige / Sweden, Czech Republic, Slovenija / Slovenia, Danmark / Denmark, Kroatien/ Croatia, Espa¿a / Spain, Aserbeidschan/ Azerbaidzan, Suomi / Finland, Brunei, France, Russland/ Russia, Great Britain, Oman, Israel.

    Quantity

    40,475 devices