Portex Lumbar Puncture Tray recalled over labeling errors

Recall date

February 28, 2020

Source

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

Official notice title

Smiths Medical ASD Inc. recalls Portex Lumbar Puncture Tray. Anesthesia Conduction Kit. 4826PL-20 - Product Usage: Portex lumbar puncture trays provide…

Recall number

Z-1820-2020

FDA classification

Class II

Brand / firm

Smiths Medical ASD Inc.

Sold / distributed

US Nationwide distribution in the states of MA, MD, MO and IN.

Why it was recalled

Cases of Portex¿ Lumbar Puncture Tray Child, SKU #4826PL-20 had been mislabeled with invalid information. The product was correct, but the inner trays were labeled as 4824PL-20 instead of 4826PL-20.

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

What was recalled

Portex Lumbar Puncture Tray. Anesthesia Conduction Kit. 4826PL-20 - Product Usage: Portex lumbar puncture trays provide all the materials necessary to measure cerebrospinal fluid pressure and/or collect cerebrospinal fluid specimens. Key components include skin prep materials, lancet-point needle, manometer with stopcock and extension set, and specimen vials.