Z-3196-2018 Class III Terminated
Recall Details
- Product Type
- Devices
- Report Date
- September 26, 2018
- Initiation Date
- July 13, 2018
- Termination Date
- October 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.