Z-1820-2020 Class II Terminated
FDA device recall Z-1820-2020 was initiated by Smiths Medical ASD Inc. on February 28, 2020 and is designated Class II. 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. The recall status is terminated (terminated September 1, 2021). Affected quantity: 100 units..
Recall Details
- Product Type
- Devices
- Report Date
- May 6, 2020
- Initiation Date
- February 28, 2020
- Termination Date
- September 1, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 100 units.
Product Description
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.
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.
Distribution Pattern
US Nationwide distribution in the states of MA, MD, MO and IN.
Code Information
Lot #3842192, Model no. 4826PL-20.