FDA recall Z-3196-2018

Product

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

US Nationwide Distribution in the states of CT, MA, MI, NC, NJ, NY, RI, TX, UT, and WA.

Key facts

Status

Terminated

Initiation date

2018-07-13

Report date

2018-09-26

Termination date

2018-10-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Minneapolis, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3196-2018