—#180714

Product

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.

FDA product code: CAZ — Anesthesia Conduction Kit
Device class: Class 2
Medical specialty: Anesthesiology
510(k) numbers: K172410
Affected lot / code info: Lot #3842192, Model no. 4826PL-20.

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.

Root cause (FDA determination)

Labeling mix-ups

Action the firm took

Smiths Medical notified customers on 03/21/2020 via "urgent Medical Device Recall" letter. The letter identified the affected product and instructed to customers to quarantine and return the affected product. The firm also instructed the customers to notify their customers if the affected product was further distributed.

Recalling firm

Firm: Smiths Medical ASD Inc.
Address: 6000 Nathan Ln N, Minneapolis, Minnesota 55442-1690

Distribution

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

Timeline

Recall initiated: 2020-02-28
Terminated: 2021-09-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #180714. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.