Z-3196-2018 Class III Terminated
FDA device recall Z-3196-2018 was initiated by Smiths Medical ASD Inc. on Jul 13, 2018 and is designated Class III. Reason for recall: The product was mislabeled with the incorrect label. The recall status is terminated (terminated Oct 19, 2018). Affected quantity: 29,600 kits.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 26, 2018
- Initiation Date
- Jul 13, 2018
- Termination Date
- Oct 19, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 29,600 kits
Product Description
Portex Pulsator Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4080P-2, Sterile, RX. The firm name on the label is Smiths Medical ASD, Inc., Keene, NH.
Reason for Recall
The product was mislabeled with the incorrect label.
Distribution Pattern
US Nationwide Distribution in the states of CT, MA, MI, NC, NJ, NY, RI, TX, UT, and WA.
Code Information
Lot numbers 3306404, 3314069, and 3318698.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-3196-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026