Z-1820-2020Class II

Portex Lumbar Puncture Tray. Anesthesia Conduction Kit. 4826PL-20 -

Name: Z-1820-2020 Portex Lumbar Puncture Tray. Anesthesia Conduction Kit. 4826PL-20 -
Creator: Smiths Medical ASD Inc.
Published: 2020-02-28
License: https://open.fda.gov/license/

Abbott Medical / initiated 2020-02-28 / Terminated / root cause: labeling and UDI

FDA source

Smiths Medical ASD Inc. began a recall of Portex Lumbar Puncture Tray. Anesthesia Conduction Kit. 4826PL-20 - Product Usage: Portex lumbar puncture trays provide all the materials necessary to measure... on 2020-02-28. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1820-2020
Classification: Class II
Status: Terminated
Initiated: 2020-02-28
Posted: 2020-04-29
Terminated: 2021-09-01
Recalling firm: Abbott Medical
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.
Product code: CAZ Anesthesia Conduction Kit
Reason for recall: 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 tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: 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.
Quantity in commerce: 100 units.
Distribution: US Nationwide distribution in the states of MA, MD, MO and IN.
Product codes and lots: Lot #3842192, Model no. 4826PL-20.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1820-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1820-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-06	2020-04-29

Product code CAZ

K172410Class IIPortex NRFit Epidural Needles, Portex NRFit Spinal Needles, Portex NRFit Loss of Resistance (L.O.R.) Syringes., Portex EpiFuse Catheter Connector, Portex Regional Anaesthesia Portfolio FiltersSmiths Medical Asd, Inc. / cleared 2018-06-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)