Recall Z-1820-2020 ยท CAZ Anesthesia Conduction Kit
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.
| Date | Feb 28, 2020 |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K172410 | Portex NRFit Epidural Needles, Portex NRFit Spinal Needles, Portex NRFit Loss of Resistance (L.O.R.) Syringes., Portex E Smiths Medical Asd, Inc., Jun 1, 2018 |