Device 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.
Z-1820-2020
Product summary
- Event
- Event 85375
- Status
- Terminated
- Classification
- Class II
- Quantity
- 100 units.
- Official record key
device-enforcement:Z-1820-2020
Official wording
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.
Code information: Lot #3842192, Model no. 4826PL-20.
Distribution pattern: US Nationwide distribution in the states of MA, MD, MO and IN.
Derived failure modes
-
Labeling or packaging
mislabeled