CLASS II Device recall · Reported 6 May 2020 · FDA Enforcement Report
Portex Lumbar Puncture Tray recalled by Smiths Medical ASD
Smiths Medical ASD is recalling Portex Lumbar Puncture Tray, distributed nationwide in the US. The recall was initiated on 28 Feb 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1820-2020
- FDA event ID
- 85375
- Recalling firm
- Smiths Medical ASD, Minneapolis, MN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 28 Feb 2020
- FDA classified
- 29 Apr 2020
- Reported
- 6 May 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Insulin Pumps & Glucose Monitors
Timeline
| 28 Feb 2020 | Recall initiated by company | |
| 29 Apr 2020 | Classified by FDA | +61 days |
| 6 May 2020 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide distribution in the states of MA, MD, MO and IN.
Questions about this recall
Why was it 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.
Which lots are affected?
Lot #3842192, Model no. 4826PL-20.
Where was it sold?
US Nationwide distribution in the states of MA, MD, MO and IN.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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