FDA Medical Device Recalls (openFDA)
Smiths Medical ASD Inc.: 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.
- Recall number
- Z-1820-2020
- Recalling firm
- Smiths Medical ASD Inc.
- 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.
- Status
- Terminated
- Initiated
- 2020-02-28
- Posted
- not on file
- Terminated
- 2021-09-01
- Reason
- 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
- 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
- 100 units.
- Distribution
- US Nationwide distribution in the states of MA, MD, MO and IN.
- Lot, serial or model codes
- Lot #3842192, Model no. 4826PL-20.
- 510(k) numbers
- ["K172410"]
- PMA numbers
- not on file
- Product code
- CAZ
- Firm FEI
- 3012307300
- Firm city
- Minneapolis
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28