Pajunk GmbH recalls SPROTTE Lumbar with Introducer, labeled as the following: 1. Sprotte 22G x 90mm w/ introducer and wings (25/box); 2. Sp…

Recall date

August 30, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0234-2020

FDA classification

Class II

Brand / firm

Pajunk GmbH

Sold / distributed

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 / Net…

Why it was recalled

Problem with packaging sealing process which affects sterility.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.